JPWO2021252319A5 - - Google Patents
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- JPWO2021252319A5 JPWO2021252319A5 JP2022571788A JP2022571788A JPWO2021252319A5 JP WO2021252319 A5 JPWO2021252319 A5 JP WO2021252319A5 JP 2022571788 A JP2022571788 A JP 2022571788A JP 2022571788 A JP2022571788 A JP 2022571788A JP WO2021252319 A5 JPWO2021252319 A5 JP WO2021252319A5
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- 210000001747 pupil Anatomy 0.000 claims description 44
- 210000001525 retina Anatomy 0.000 claims description 27
- 230000002093 peripheral effect Effects 0.000 claims description 25
- 230000003287 optical effect Effects 0.000 claims description 24
- 238000005286 illumination Methods 0.000 claims description 22
- 230000000638 stimulation Effects 0.000 claims description 12
- 208000014733 refractive error Diseases 0.000 claims description 8
- 238000011282 treatment Methods 0.000 claims description 8
- 230000002911 mydriatic effect Effects 0.000 claims description 4
- 230000002207 retinal effect Effects 0.000 claims description 4
- 230000008878 coupling Effects 0.000 claims description 2
- 238000010168 coupling process Methods 0.000 claims description 2
- 238000005859 coupling reaction Methods 0.000 claims description 2
- 230000010339 dilation Effects 0.000 claims description 2
- 230000004936 stimulating effect Effects 0.000 claims description 2
- 230000000007 visual effect Effects 0.000 claims description 2
- 239000003814 drug Substances 0.000 claims 1
- 229940079593 drug Drugs 0.000 claims 1
- 238000000034 method Methods 0.000 description 27
- 230000004323 axial length Effects 0.000 description 3
- 229940124570 cycloplegic agent Drugs 0.000 description 3
- 239000000634 cycloplegic agent Substances 0.000 description 3
- 229930003347 Atropine Natural products 0.000 description 2
- RKUNBYITZUJHSG-UHFFFAOYSA-N Hyosciamin-hydrochlorid Natural products CN1C(C2)CCC1CC2OC(=O)C(CO)C1=CC=CC=C1 RKUNBYITZUJHSG-UHFFFAOYSA-N 0.000 description 2
- 206010025421 Macule Diseases 0.000 description 2
- RKUNBYITZUJHSG-SPUOUPEWSA-N atropine Chemical compound O([C@H]1C[C@H]2CC[C@@H](C1)N2C)C(=O)C(CO)C1=CC=CC=C1 RKUNBYITZUJHSG-SPUOUPEWSA-N 0.000 description 2
- 229960000396 atropine Drugs 0.000 description 2
- 230000000916 dilatatory effect Effects 0.000 description 2
- 229930000680 A04AD01 - Scopolamine Natural products 0.000 description 1
- ZTVIKZXZYLEVOL-MCOXGKPRSA-N Homatropine Chemical compound O([C@H]1C[C@H]2CC[C@@H](C1)N2C)C(=O)C(O)C1=CC=CC=C1 ZTVIKZXZYLEVOL-MCOXGKPRSA-N 0.000 description 1
- STECJAGHUSJQJN-GAUPFVANSA-N Hyoscine Natural products C1([C@H](CO)C(=O)OC2C[C@@H]3N([C@H](C2)[C@@H]2[C@H]3O2)C)=CC=CC=C1 STECJAGHUSJQJN-GAUPFVANSA-N 0.000 description 1
- STECJAGHUSJQJN-UHFFFAOYSA-N N-Methyl-scopolamin Natural products C1C(C2C3O2)N(C)C3CC1OC(=O)C(CO)C1=CC=CC=C1 STECJAGHUSJQJN-UHFFFAOYSA-N 0.000 description 1
- BGDKAVGWHJFAGW-UHFFFAOYSA-N Tropicamide Chemical compound C=1C=CC=CC=1C(CO)C(=O)N(CC)CC1=CC=NC=C1 BGDKAVGWHJFAGW-UHFFFAOYSA-N 0.000 description 1
- SKYSRIRYMSLOIN-UHFFFAOYSA-N cyclopentolate Chemical compound C1CCCC1(O)C(C(=O)OCCN(C)C)C1=CC=CC=C1 SKYSRIRYMSLOIN-UHFFFAOYSA-N 0.000 description 1
- 229960001815 cyclopentolate Drugs 0.000 description 1
- 229960000857 homatropine Drugs 0.000 description 1
- 229960002646 scopolamine Drugs 0.000 description 1
- STECJAGHUSJQJN-FWXGHANASA-N scopolamine Chemical compound C1([C@@H](CO)C(=O)O[C@H]2C[C@@H]3N([C@H](C2)[C@@H]2[C@H]3O2)C)=CC=CC=C1 STECJAGHUSJQJN-FWXGHANASA-N 0.000 description 1
- 229960004791 tropicamide Drugs 0.000 description 1
Description
屈折異常を治療するための装置は、焦点から外れた画像を備える、刺激を、黄斑の外側の周辺網膜上に投影するように構成される、１つまたはそれを上回る光学系を備える。刺激は、多くの方法で構成されることができるが、いくつかの実施形態では、刺激は、黄斑視等の中心視への干渉を減少させるように配列される。刺激は、約２ジオプタ（「Ｄ」）～約６Ｄの範囲内の脱焦点化の量を備え得る、焦点から外れた画像であることができ、範囲は、約３Ｄ～約６Ｄであることができる。いくつかの実施形態では、刺激の明度は、背景明度の少なくとも３倍等、適切な量だけ背景照明の明度を上回る。いくつかの実施形態では、複数の刺激はそれぞれ、約１Ｘ１０－１～１Ｘ１０１サイクル／度の範囲内の実質的空間周波数を有する、振幅プロファイルを伴う、空間周波数分布を備える。いくつかの実施形態では、刺激はそれぞれ、刺激に対する応答を助長するための空間周波数を提供するような強度プロファイル分布を伴って、定寸および成形される。刺激はそれぞれ、減少された照明の領域に近接して、１つまたはそれを上回る局在化された強度ピークを備えてもよい。いくつかの実施形態では、減少された照明の領域は、複数のピーク間に位置するが、減少された照明の領域は、環状ピークによって境界されてもよい。
本発明は、例えば、以下を提供する。
（項目１）
眼の屈折異常を治療するための装置であって、前記装置は、
複数の刺激と、
１つまたはそれを上回る光学系であって、前記１つまたはそれを上回る光学系は、前記複数の刺激を網膜の周辺部分の前方または後方に結像し、複数の脱焦点化された画像を前記網膜の周辺部分上に形成する、１つまたはそれを上回る光学系と
を備え、前記複数の刺激および前記１つまたはそれを上回る光学系は、前記眼の中心視への干渉を低減させるように配列される、装置。
（項目２）
前記複数の画像は、３．０Ｄ～６．０Ｄの範囲内の量だけ脱焦点化される、随意に、近視眼的に、随意に、３．５Ｄ～５．０Ｄの範囲内で脱焦点化される、項目１に記載の装置。
（項目３）
前記複数の脱焦点化された画像の明度は、背景照明の明度の少なくとも３倍、随意に、背景照明の明度の少なくとも５倍、随意に、背景照明の明度の３～２０倍の範囲内、さらに随意に、背景照明の明度の５～１５倍の範囲内でより高い、項目１に記載の装置。
（項目４）
前記複数の脱焦点化された画像はそれぞれ、強度プロファイル分布を備え、前記強度プロファイル分布は、１つまたはそれを上回るピークに対して減少された強度を伴う内側部分の周囲に分散された１つまたはそれを上回るピークを備える、項目１に記載の装置。
（項目５）
前記１つまたはそれを上回るピークは、複数のピークを備え、前記内側部分は、前記複数のピーク間に位置する、項目４に記載の装置。
（項目６）
前記複数のピークは、４つのピークを備え、前記内側部分は、前記４つのピーク間に位置する、項目５に記載の装置。
（項目７）
前記内側部分は、前記４つのピーク間に延在する十字を備える、項目６に記載の装置。
（項目８）
前記１つまたはそれを上回るピークは、環状ピークを備え、前記内側部分は、前記環状ピーク内に位置する、項目４に記載の装置。
（項目９）
前記複数の脱焦点化された画像はそれぞれ、多色性アイコンをより暗い背景上に備え、コントラストを提供し、随意に、前記多色性アイコンは、白色アイコンを備え、前記より暗い背景は、実質的に黒色背景を備える、項目１に記載の装置。
（項目１０）
前記複数の刺激はそれぞれ、長さ、縁、および強度プロファイル分布を備え、前記網膜の前方または後方において前記眼の中に結像される際に、１Ｘ１０
－１
～２．５Ｘ１０
１
サイクル／度の範囲内、随意に、１Ｘ１０
－１
～１Ｘ１０
１
サイクル／度の範囲内の空間周波数を生成する、項目１に記載の装置。
（項目１１）
前記眼内に結像される際の前記複数の刺激は、約１Ｘ１０
－１
～約２．５Ｘ１０
１
サイクル／度、随意に、１Ｘ１０
－１
～約５Ｘ１０
０
サイクル／度の空間周波数の範囲にわたって、空間周波数の増加に伴って空間周波数振幅の減少を提供する空間周波数分布を備える、項目１に記載の装置。
（項目１２）
前記空間周波数強度の減少は、任意単位における前記空間周波数振幅にわたって、１／（空間周波数）
０．５
～１／（空間周波数）
２
、随意に、任意単位における前記空間周波数振幅にわたって、１／（空間周波数）～１／（空間周波数）
２
の範囲内である、項目１１に記載の装置。
（項目１３）
前記空間周波数の範囲は、約３Ｘ１０
－１
～約１．０Ｘ１０
１
サイクル／度、随意に、約３Ｘ１０
－１
～約２．０Ｘ１０
０
の範囲内、さらに随意に、約３Ｘ１０
－１
～約１．０Ｘ１０
０
である、項目１１に記載の装置。
（項目１４）
前記装置は、患者の眼の単眼刺激のために構成される、項目１に記載の装置。
（項目１５）
前記装置は、前記患者の両眼刺激のために構成される、項目１に記載の装置。
（項目１６）
前記患者の僚眼を刺激する第２の複数の刺激と、
第２の１つまたはそれを上回る光学系であって、前記第２の１つまたはそれを上回る光学系は、前記第２の複数の刺激を前記僚眼の網膜の周辺部分の前方または後方に結像し、第２の複数の脱焦点化された画像を前記第２の網膜の周辺部分上に形成する、第２の１つまたはそれを上回る光学系と
をさらに備え、
前記第２の複数の刺激および前記第２の１つまたはそれを上回る光学系は、前記僚眼の中心視への干渉を低減させるように配列される、項目１５に記載の装置。
（項目１７）
前記複数の刺激および前記１つまたはそれを上回る光学系は、１０度～３０度の範囲内、随意に、１０度～２０度、随意に、１２度～１８度の範囲内の実質的に中断されない視野を提供するように配列される、随意に、前記複数の脱焦点化された画像はそれぞれ、前記視野の外側の前記網膜上に投影される、項目１に記載の装置。
（項目１８）
前記眼内に結像される際の前記複数の刺激はそれぞれ、略均一灰色背景上にオーバーレイされ、前記複数の刺激はそれぞれ、白色アイコンを備え、したがって、前記アイコンは、主に、１Ｘ１０
－１
サイクル／度～２．５Ｘ１０
１
サイクル／度の範囲内、随意に、１Ｘ１０
－１
サイクル／度～１Ｘ１０
１
サイクル／度の範囲内の空間周波数の特徴を生成する縁の全長を有する、項目１に記載の装置。
（項目１９）
前記眼内に結像される際の前記複数の刺激はそれぞれ、主に、１Ｘ１０
－１
サイクル／度～２．５Ｘ１０
１
サイクル／度の範囲内、随意に、１Ｘ１０
－１
サイクル／度～１Ｘ１０
１
サイクル／度の範囲内の空間周波数の特徴を生成する縁プロファイルを背景上に有する多色性アイコンを備える、項目１に記載の装置。
（項目２０）
前記複数の刺激はそれぞれ、０．７を上回る、随意に、８．０を上回る大域的コントラスト係数を備える、項目１に記載の装置。
（項目２１）
前記１つまたはそれを上回る光学系は、ホログラム、導波管、ミラー、レンズ、眼鏡レンズ、またはコンタクトレンズのうちの１つまたはそれを上回るものを備える、項目１に記載の装置。
（項目２２）
前記ユーザに結合し、前記１つまたはそれを上回る光学系を支持するための支持体をさらに備え、前記支持体は、頭部搭載型デバイス、眼鏡レンズ、眼鏡フレーム、ゴーグル、ＡＲディスプレイ、コンタクトレンズ、またはＶＲディスプレイのうちの１つまたはそれを上回るもののコンポーネントを備える、項目１に記載の装置。
（項目２３）
前記眼の屈折異常を補正するためのレンズをさらに備える、項目１に記載の装置。
（項目２４）
前記１つまたはそれを上回る光学系は、前記眼の瞳孔が散瞳薬で拡張されているとき、前記複数の刺激を前記網膜の周辺部分に向かって投影するように配列される、項目１に記載の装置。
（項目２５）
前記複数の刺激は、前記眼の視軸から少なくとも３５度の角度で、前記網膜の周辺部分を照明するように配列される、項目２４に記載の装置。
（項目２６）
前記瞳孔のサイズを測定するためのセンサをさらに備え、前記瞳孔のサイズに応答して、前記光学刺激を前記眼に向かって指向するための命令とともに構成されるプロセッサをさらに備え、随意に、前記瞳孔のサイズは、前記瞳孔の直径を備える、項目１に記載の装置。
（項目２７）
前記プロセッサは、前記瞳孔のサイズに応答して、前記光学刺激の強度または持続時間のうちの１つまたはそれを上回るものを調節するように構成される、項目２６に記載の装置。
（項目２８）
前記センサは、センサアレイを備え、随意に、前記センサアレイは、カメラのセンサアレイを備える、項目２６に記載の装置。
（項目２９）
前記複数の刺激は、複数の刺激で照明されると、天然瞳孔の拡張を可能にするように構成される、項目２６に記載の装置。
（項目３０）
前記複数の刺激は、前記刺激が提供されるとき、前記刺激がまだ提供されていないときの前記瞳孔の直径と比較して、１ミリメートル（ｍｍ）以下だけ前記瞳孔を収縮させるように構成される、項目１に記載の装置。
（項目３１）
前記瞳孔は、前記眼が、前記複数の刺激に暴露されるとき、刺激直径を備え、前記眼は、前記眼が、前記複数の刺激を伴わずに、明所視視認条件に暴露されるとき、明所視直径を備え、前記明所視直径は、前記刺激直径より少なくとも１ミリメートル小さく、随意に、前記明所視視認条件は、少なくとも３カンデラ（ｃｄ）／平方メートル（ｍ
２
）の輝度を備える、項目１に記載の装置。
（項目３２）
前記刺激は、３５度を上回る偏心を伴って、前記網膜の周辺部分を照明するように構成され、前記眼の瞳孔は、前記刺激が、前記３５度を上回る偏心を伴って、前記周辺網膜に提供されている間、明所視照明と比較して、少なくとも約１ミリメートルだけ拡張される、項目１に記載の装置。
（項目３３）
前記複数の刺激のエネルギーの総量の１０％以下、随意に、前記総量の５％以下、随意に、前記総量の１％以下が、前記複数の刺激に応答して、前記瞳孔の収縮を減少させるために、前記眼の中心窩に指向される、項目１に記載の装置。
（項目３４）
眼の屈折異常を治療する方法であって、前記方法は、
刺激を前記眼の網膜の周辺領域に提供することを含み、前記刺激は、朝に提供される、方法。
（項目３５）
前記刺激は、前記先行項目のうちの任意の１つに記載の装置によって提供される、項目３４に記載の方法。
（項目３６）
前記刺激は、午前６時～午前１０時に提供される、項目３４に記載の方法。
（項目３７）
前記刺激は、午前６時～午前１０時に提供される、項目３４に記載の方法。
（項目３８）
前記刺激は、複数の連続する日の朝に前記眼に提供され、それぞれの日の総治療時間は、１時間以下を含む、項目３４に記載の方法。
（項目３９）
プロセッサによって実行されるための命令とともに構成される有形媒体であって、前記有形媒体は、項目３４－３８のいずれか１項に記載の方法を実施するように構成される、有形媒体。
（項目４０）
患者データベースであって、
複数の患者に関する複数の網膜刺激治療に対応する治療データと、
前記複数の患者に関する有効性データであって、前記有効性データは、前記複数の治療に関する屈折データを備える、有効性データと
を備える、患者データベース。
（項目４１）
臨床試験を行う方法であって、前記方法は、
複数の日のそれぞれの日に、周辺網膜刺激を試験眼に提供し、対照眼に提供しないことと、
複数の日のそれぞれの日に、治療前および後の前記試験眼および前記対照眼の軸方向長を測定することと、
前記試験眼の軸方向長と前記対照眼の軸方向長を比較し、前記周辺網膜刺激の有効性を決定することと
を含む、方法。
（項目４２）
眼の屈折異常を治療する方法であって、前記方法は、
前記眼の瞳孔を拡張させることと、
光学刺激を前記網膜の周辺部分に提供し、前記眼の屈折異常を減少させることと
を含む、方法。
（項目４３）
前記刺激は、前記項目のいずれか１項に記載の前記複数の刺激を備える、項目４２に記載の方法。
（項目４４）
前記瞳孔は、散瞳薬で拡張される、項目４２に記載の方法。
（項目４５）
前記散瞳薬は、毛様体筋麻痺薬を備え、随意に、前記毛様体筋麻痺薬は、アトロピン、シクロペントラート、ホマトロピン、スコポラミン、およびトロピカミドから成る群から選択される、項目４４に記載の方法。
（項目４６）
前記毛様体筋麻痺薬は、０．０２５％～０．２％、随意に、０．０５％～０．１％の範囲内のパーセンテージ重量比を伴うアトロピンを備える、項目４５に記載の方法。
（項目４７）
前記瞳孔のサイズは、測定され、前記光学刺激は、前記瞳孔のサイズに応答して、前記眼に向かって指向され、随意に、前記瞳孔のサイズは、前記瞳孔の直径を備える、項目４２に記載の方法。
（項目４８）
前記光学刺激の強度または持続時間のうちの１つまたはそれを上回るものは、前記瞳孔のサイズに応答して調節される、項目４７に記載の方法。
（項目４９）
前記瞳孔のサイズは、センサを用いて測定され、随意に、前記センサは、センサアレイを備え、随意に、前記センサアレイは、カメラのセンサアレイを備える、項目４７に記載の方法。
（項目５０）
前記瞳孔は、前記周辺網膜の適切な量の照明および前記天然瞳孔を通して通過する他の源からの光で拡張された前記眼の天然瞳孔を備え、随意に、前記天然瞳孔は、前記眼への照明に応答して収縮および拡張することが可能である、項目４２に記載の方法。
（項目５１）
前記天然瞳孔は、薄明視背景照明または暗所視背景照明で拡張され、随意に、前記薄明視背景照明は、０．０１カンデラ／平方メートル（ｃｄ／ｍ
２
）～３ｃｄ／ｍ
２
の範囲内の量を備える、項目５０に記載の方法。
（項目５２）
前記天然瞳孔は、前記刺激が提供されるとき、前記刺激がまだ提供されていないときの前記天然瞳孔の直径と比較して、１ミリメートル（ｍｍ）以下だけ収縮する、項目５１に記載の方法。
（項目５３）
前記天然瞳孔は、前記眼が前記刺激に暴露されるとき、刺激直径を備え、前記天然瞳孔は、前記眼が明所視視認条件に暴露されるとき、明所視直径を備え、前記明所視直径は、前記刺激直径より少なくとも１ミリメートル小さい、項目５１に記載の方法。
（項目５４）
前記刺激は、３５度を上回る偏心を伴って、前記周辺網膜を照明するように構成され、前記瞳孔は、前記刺激が、前記３５度を上回る偏心を伴って、前記周辺網膜に提供される間、明所視照明と比較して、少なくとも約１ミリメートルだけ拡張される、項目４２に記載の方法。
（項目５５）
前記複数の刺激のエネルギーの総量の１０％以下、随意に、前記総量の５％以下、随意に、前記総量の１％以下が、前記複数の刺激に応答して、前記瞳孔の収縮を減少させるために、前記眼の中心窩に指向される、項目４２に記載の方法。
（項目５６）
前記刺激は、前記網膜の前記周辺領域に指向される明所視刺激を備え、中心窩または黄斑のうちの１つまたはそれを上回るものの照明は、瞳孔のサイズを減少させるために、薄明視または暗所視照明のうちの１つまたはそれを上回るものを備える、項目４２に記載の方法。
（参照による組み込み）
A device for treating refractive error comprises one or more optical systems configured to project a stimulus comprising an out-of-focus image onto the peripheral retina outside the macula. The stimulus can be configured in many ways, but in some embodiments, the stimulus is arranged to reduce interference with central vision, such as macular vision. The stimulus can be an out-of-focus image that may comprise an amount of defocusing in the range of about 2 diopters ("D") to about 6D, and the range can be from about 3D to about 6D. In some embodiments, the brightness of the stimulus exceeds the brightness of the background illumination by an appropriate amount, such as at least three times the brightness of the background. In some embodiments, each of the multiple stimuli comprises a spatial frequency distribution with an amplitude profile having a substantial spatial frequency in the range of about 1×10 −1 to 1×10 1 cycles per degree. In some embodiments, each of the stimuli is sized and shaped with an intensity profile distribution to provide a spatial frequency to facilitate a response to the stimulus. Each of the stimuli may comprise one or more localized intensity peaks in proximity to the area of reduced illumination. In some embodiments, the region of reduced illumination is located between multiple peaks, however, the region of reduced illumination may be bounded by annular peaks.
The present invention provides, for example, the following:
(Item 1)
1. An apparatus for treating refractive error of an eye, the apparatus comprising:
Multiple stimuli and
one or more optical systems that image the plurality of stimuli in front of or behind a peripheral portion of a retina to form a plurality of defocused images on the peripheral portion of the retina;
wherein the plurality of stimuli and the one or more optical systems are arranged to reduce interference with central vision of the eye.
(Item 2)
2. The apparatus of claim 1, wherein the plurality of images are defocused by an amount in the range of 3.0D to 6.0D, optionally myopically, optionally defocused within the range of 3.5D to 5.0D.
(Item 3)
2. The apparatus of claim 1, wherein a brightness of the plurality of defocused images is at least 3 times higher than a brightness of the background illumination, optionally at least 5 times higher than a brightness of the background illumination, optionally within a range of 3 to 20 times higher than a brightness of the background illumination, further optionally within a range of 5 to 15 times higher than a brightness of the background illumination.
(Item 4)
2. The apparatus of claim 1, wherein each of the plurality of defocused images comprises an intensity profile distribution comprising one or more peaks distributed around an inner portion with reduced intensity relative to the one or more peaks.
(Item 5)
5. The apparatus of claim 4, wherein the one or more peaks comprise a plurality of peaks and the inner portion is located between the plurality of peaks.
(Item 6)
6. The apparatus of claim 5, wherein the plurality of peaks comprises four peaks and the inner portion is located between the four peaks.
(Item 7)
7. The apparatus of claim 6, wherein the inner portion comprises a cross extending between the four peaks.
(Item 8)
5. The apparatus of claim 4, wherein the one or more peaks comprise an annular peak and the inner portion is located within the annular peak.
(Item 9)
2. The apparatus of claim 1, wherein each of the plurality of defocused images comprises a multi-chromatic icon on a darker background to provide contrast, and optionally, the multi-chromatic icon comprises a white icon and the darker background comprises a substantially black background.
(Item 10)
2. The apparatus of claim 1, wherein each of the plurality of stimuli has a length, edge, and intensity profile distribution and, when imaged into the eye in front of or behind the retina, produces a spatial frequency in the range of 1×10 −1 to 2.5× 10 1 cycle/degree, optionally in the range of 1×10 −1 to 1×10 1 cycle/degree.
(Item 11)
2. The device of claim 1, wherein the plurality of stimuli when imaged into the eye comprises a spatial frequency distribution that provides a decrease in spatial frequency amplitude with increasing spatial frequency over a range of spatial frequencies from about 1×10 −1 to about 2.5 × 10 1 cycles/degree, optionally from 1×10 −1 to about 5× 10 0 cycles/degree.
(Item 12)
12. The apparatus of claim 11, wherein the reduction in spatial frequency intensity is in the range of 1/(spatial frequency) 0.5 to 1/(spatial frequency) 2 across the spatial frequency amplitude in arbitrary units, optionally in the range of 1/(spatial frequency) to 1/(spatial frequency) 2 across the spatial frequency amplitude in arbitrary units.
(Item 13)
12. The apparatus of claim 11, wherein the spatial frequency range is within the range of about 3×10 −1 to about 1.0× 10 1 cycles/degree, optionally from about 3× 10 −1 to about 2.0×10 0 , further optionally from about 3×10 −1 to about 1.0×10 0 .
(Item 14)
13. The device of claim 1, wherein the device is configured for monocular stimulation of a patient's eye.
(Item 15)
2. The device of claim 1, wherein the device is configured for binocular stimulation of the patient.
(Item 16)
a second plurality of stimuli for stimulating the patient's fellow eye; and
a second one or more optical systems that images the second plurality of stimuli in front of or behind a peripheral portion of the retina of the fellow eye and form a second plurality of defocused images on the peripheral portion of the second retina;
Further equipped with
16. The device of claim 15, wherein the second plurality of stimuli and the second one or more optical systems are arranged to reduce interference with central vision of the fellow eye.
(Item 17)
2. The apparatus of claim 1, wherein the plurality of stimuli and the one or more optical systems are arranged to provide a substantially uninterrupted field of view within a range of 10 degrees to 30 degrees, optionally within a range of 10 degrees to 20 degrees, optionally within a range of 12 degrees to 18 degrees; optionally, each of the plurality of defocused images is projected onto the retina outside the field of view.
(Item 18)
2. The apparatus of claim 1, wherein each of the plurality of stimuli as imaged into the eye is overlaid on a substantially uniform grey background, and each of the plurality of stimuli comprises a white icon, such that the icon has a total edge length that produces spatial frequency features primarily within a range of 1× 10 −1 cycles/degree to 2.5×10 1 cycles/degree, optionally within a range of 1×10 −1 cycles/degree to 1×10 1 cycles/degree.
(Item 19)
2. The apparatus of claim 1 , wherein each of the plurality of stimuli when imaged into the eye comprises a polychromatic icon having an edge profile on a background that produces spatial frequency features primarily within a range of 1× 10 −1 cycles/ degree to 2.5× 10 1 cycles/degree, optionally within a range of 1×10 −1 cycles/degree to 1×10 1 cycles/degree.
(Item 20)
2. The apparatus of claim 1, wherein each of the plurality of stimuli comprises a global contrast coefficient greater than 0.7, optionally greater than 8.0.
(Item 21)
2. The apparatus of claim 1, wherein the one or more optical systems comprise one or more of a hologram, a waveguide, a mirror, a lens, an eyeglass lens, or a contact lens.
(Item 22)
Item 1, the apparatus of item 1 further comprising a support for coupling to the user and supporting the one or more optical systems, the support comprising a component of one or more of a head mounted device, an eyeglass lens, an eyeglass frame, goggles, an AR display, a contact lens, or a VR display.
(Item 23)
2. The device of claim 1, further comprising a lens for correcting refractive error of the eye.
(Item 24)
13. The device of claim 1, wherein the one or more optical systems are arranged to project the plurality of stimuli toward a peripheral portion of the retina when the pupil of the eye is dilated with a mydriatic.
(Item 25)
25. The apparatus of claim 24, wherein the plurality of stimuli are arranged to illuminate a peripheral portion of the retina at an angle of at least 35 degrees from the visual axis of the eye.
(Item 26)
13. The device of claim 1, further comprising a sensor for measuring a size of the pupil, and further comprising a processor configured with instructions for directing the optical stimulus towards the eye in response to a size of the pupil, optionally wherein the size of the pupil comprises a diameter of the pupil.
(Item 27)
27. The apparatus of claim 26, wherein the processor is configured to adjust one or more of an intensity or duration of the optical stimulus in response to a size of the pupil.
(Item 28)
27. The apparatus of claim 26, wherein the sensor comprises a sensor array, and optionally the sensor array comprises a sensor array of a camera.
(Item 29)
27. The apparatus of claim 26, wherein the plurality of stimuli are configured to enable dilation of a natural pupil when illuminated with the plurality of stimuli.
(Item 30)
2. The device of claim 1, wherein the plurality of stimuli are configured to constrict the pupil by 1 millimeter (mm) or less when the stimuli are provided compared to a diameter of the pupil when the stimuli are not yet provided.
(Item 31)
2. The device of claim 1, wherein the pupil comprises a stimulus diameter when the eye is exposed to the plurality of stimuli, and the eye comprises a photopic diameter when the eye is exposed to photopic viewing conditions without the plurality of stimuli, the photopic diameter being at least 1 millimeter smaller than the stimulus diameter, and optionally, the photopic viewing conditions comprising a luminance of at least 3 candelas (cd) per square meter (m2 ) .
(Item 32)
2. The device of claim 1, wherein the stimulus is configured to illuminate a peripheral portion of the retina with an eccentricity greater than 35 degrees, and wherein the pupil of the eye is dilated by at least about 1 millimeter compared to photopic illumination while the stimulus is presented to the peripheral retina with an eccentricity greater than 35 degrees.
(Item 33)
2. The device of claim 1, wherein less than 10% of a total amount of energy of the plurality of stimuli, optionally less than 5% of the total amount, optionally less than 1% of the total amount, is directed to the fovea of the eye to reduce constriction of the pupil in response to the plurality of stimuli.
(Item 34)
1. A method for treating refractive error of an eye, the method comprising:
providing a stimulus to a peripheral area of the retina of the eye, the stimulus being provided in the morning.
(Item 35)
35. The method of claim 34, wherein the stimulus is provided by an apparatus according to any one of the preceding claims.
(Item 36)
35. The method of claim 34, wherein the stimulation is provided between 6:00 am and 10:00 am.
(Item 37)
35. The method of claim 34, wherein the stimulation is provided between 6:00 am and 10:00 am.
(Item 38)
35. The method of claim 34, wherein the stimulation is provided to the eye in the morning on multiple consecutive days, the total treatment time on each day comprising 1 hour or less.
(Item 39)
39. A tangible medium configured with instructions for execution by a processor, the tangible medium configured to implement the method of any one of claims 34-38.
(Item 40)
1. A patient database comprising:
treatment data corresponding to a plurality of retinal stimulation treatments for a plurality of patients;
Efficacy data for the plurality of patients, the efficacy data comprising refraction data for the plurality of treatments;
A patient database comprising:
(Item 41)
1. A method of conducting a clinical trial, the method comprising:
providing peripheral retinal stimulation to the test eye and not to the control eye on each of the plurality of days;
measuring the axial length of the test eye and the control eye before and after treatment on each of a plurality of days;
comparing the axial length of the test eye to the axial length of the control eye to determine efficacy of the peripheral retinal stimulation;
A method comprising:
(Item 42)
1. A method for treating refractive error in an eye, the method comprising:
dilating the pupil of said eye;
providing optical stimulation to a peripheral portion of the retina to reduce refractive error of the eye;
A method comprising:
(Item 43)
43. The method of claim 42, wherein the stimuli comprise the plurality of stimuli of any one of the preceding claims.
(Item 44)
43. The method of claim 42, wherein the pupil is dilated with a mydriatic.
(Item 45)
45. The method of claim 44, wherein the mydriatic comprises a cycloplegic agent, optionally wherein the cycloplegic agent is selected from the group consisting of atropine, cyclopentolate, homatropine, scopolamine, and tropicamide.
(Item 46)
46. The method of claim 45, wherein the cycloplegic agent comprises atropine with a percentage weight ratio in the range of 0.025% to 0.2%, optionally 0.05% to 0.1%.
(Item 47)
43. The method of claim 42, wherein a size of the pupil is measured and the optical stimulus is directed towards the eye in response to a size of the pupil, optionally wherein the size of the pupil comprises a diameter of the pupil.
(Item 48)
48. The method of claim 47, wherein one or more of an intensity or duration of the optical stimulus is adjusted in response to a size of the pupil.
(Item 49)
48. The method of claim 47, wherein the pupil size is measured using a sensor, optionally the sensor comprises a sensor array, optionally the sensor array comprises a sensor array of a camera.
(Item 50)
43. The method of claim 42, wherein the pupil comprises a natural pupil of the eye dilated with an appropriate amount of illumination of the peripheral retina and light from other sources passing through the natural pupil, and optionally the natural pupil is capable of contracting and dilating in response to illumination to the eye.
(Item 51)
51. The method of claim 50, wherein the natural pupil is dilated with mesopic background illumination or scotopic background illumination, optionally the mesopic background illumination comprising an amount in the range of 0.01 candela per square meter (cd/m 2 ) to 3 cd/m 2 .
(Item 52)
52. The method of claim 51, wherein the natural pupil constricts by no more than 1 millimeter (mm) when the stimulus is provided compared to the diameter of the natural pupil when the stimulus has not yet been provided.
(Item 53)
52. The method of claim 51, wherein the natural pupil comprises a stimulus diameter when the eye is exposed to the stimulus, and the natural pupil comprises a photopic diameter when the eye is exposed to photopic viewing conditions, the photopic diameter being at least 1 millimeter smaller than the stimulus diameter.
(Item 54)
43. The method of claim 42, wherein the stimulus is configured to illuminate the peripheral retina with an eccentricity of greater than 35 degrees, and the pupil is dilated by at least about 1 millimeter compared to photopic illumination while the stimulus is provided to the peripheral retina with an eccentricity of greater than 35 degrees.
(Item 55)
43. The method of claim 42, wherein 10% or less of a total amount of energy of the plurality of stimuli, optionally 5% or less of the total amount, optionally 1% or less of the total amount, is directed to the fovea of the eye to reduce constriction of the pupil in response to the plurality of stimuli.
(Item 56)
43. The method of claim 42, wherein the stimulus comprises a photopic stimulus directed to the peripheral region of the retina, and illumination of one or more of the fovea or macula comprises one or more of mesopic or scotopic illumination to reduce pupil size.
(Incorporated by reference)
Claims (34)
複数の刺激と、
１つまたはそれを上回る光学系であって、前記１つまたはそれを上回る光学系は、前記複数の刺激を網膜の周辺部分の前方または後方に結像し、複数の脱焦点化された画像を前記網膜の周辺部分上に形成する、１つまたはそれを上回る光学系と
を備え、前記複数の刺激および前記１つまたはそれを上回る光学系は、前記眼の中心視への干渉を低減させるように配列される、装置。 1. An apparatus for treating refractive error of an eye, the apparatus comprising:
Multiple stimuli and
and one or more optical systems that image the plurality of stimuli in front of or behind a peripheral portion of the retina to form a plurality of defocused images on the peripheral portion of the retina, wherein the plurality of stimuli and the one or more optical systems are arranged to reduce interference with central vision of the eye.
第２の１つまたはそれを上回る光学系であって、前記第２の１つまたはそれを上回る光学系は、前記第２の複数の刺激を前記僚眼の網膜の周辺部分の前方または後方に結像し、第２の複数の脱焦点化された画像を前記第２の網膜の周辺部分上に形成する、第２の１つまたはそれを上回る光学系と
をさらに備え、
前記第２の複数の刺激および前記第２の１つまたはそれを上回る光学系は、前記僚眼の中心視への干渉を低減させるように配列される、請求項１５に記載の装置。 a second plurality of stimuli for stimulating the patient's fellow eye; and
a second one or more optical systems that images the second plurality of stimuli anterior to or posterior to a peripheral portion of the retina of the fellow eye and forms a second plurality of defocused images on the peripheral portion of the second retina;
16. The apparatus of claim 15, wherein the second plurality of stimuli and the second one or more optical systems are arranged to reduce interference with central vision of the fellow eye.
複数の患者に関する複数の網膜刺激治療に対応する治療データと、
前記複数の患者に関する有効性データであって、前記有効性データは、前記複数の治療に関する屈折データを備える、有効性データと
を備える、患者データベース。
1. A patient database comprising:
treatment data corresponding to a plurality of retinal stimulation treatments for a plurality of patients;
and efficacy data for the plurality of patients, the efficacy data comprising refraction data for the plurality of treatments.
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| PCT/US2021/036100 WO2021252319A1 (en) | 2020-06-08 | 2021-06-07 | Projection of defocused images on the peripheral retina to treat refractive error |
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