PureSee EDOF Versus ZCB00 Monofocal IOLs in Mild-to-Moderate Glaucoma
Clinical Outcomes, Contrast Sensitivity, and Patient Satisfaction Following Bilateral PureSee EDOF Versus ZCB00 Monofocal IOL Implantation in Patients With Mild to Moderate Primary Open-Angle Glaucoma: An Ambispective Investigator-Initiated Trial
This study is a single center, ambispective study of visual outcomes after successful bilateral cataract surgery in patients with mild to moderate primary open-angle glaucoma (POAG). Two cohorts are compared: patients with bilateral implantation of the TECNIS PureSee non-diffractive extended depth of focus intraocular lens (EDOF IOL) and patients with bilateral implantation of the TECNIS ZCB00 monofocal IOL.
調査の概要
状態
条件
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Melissa Hamann Wright, Study Staff
- 電話番号：2389 713-580-2500
- メール：Melissa.Wright@manneye.com
研究場所
-
-
Texas
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Houston、Texas、アメリカ、77004
- Mann Eye Institute
-
コンタクト：
- Melissa Hamann Wright
- 電話番号：2389 713-580-2500
- メール：Melissa.Wright@manneye.com
-
主任研究者：
- Phillip Brunson, OD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Patients aged 45 years and older who underwent bilateral cataract surgery with bilateral implantation of either PureSee EDOF or TECNIS ZCB00, with bilateral mild or moderate primary open-angle glaucoma.
説明
Inclusion Criteria:
Age ≥45 years. Prior bilateral cataract surgery with bilateral implantation of either PureSee EDOF or TECNIS ZCB00 on or after March 12, 2026.
Intended postoperative refractive target between plano and -0.50 D in each eye. No intentional monovision. Bilateral mild or moderate POAG according to AAO ICD-10 staging criteria. Reliable glaucoma visual field available within approximately 18 months before cataract surgery or study enrollment, when available.
Reliable optical coherence tomography examination within 6 months. Adequately controlled IOP and clinically stable glaucoma in the investigator's opinion.
Prior SLT is permitted. Concurrent MIGS at the time of cataract surgery is permitted when clinically indicated at the discretion of the treating surgeon.
Ability to complete the study-specific examination and questionnaires. Study visit occurring 3-18 months following second-eye cataract surgery.
Exclusion Criteria:
Severe POAG or glaucomatous visual field loss involving fixation. Secondary glaucoma, including pseudoexfoliative, pigmentary, angle-closure, neovascular, or uveitic glaucoma.
Glaucoma surgery other than eligible concurrent MIGS that may materially influence study outcomes.
Corneal pathology or irregular astigmatism affecting visual outcomes. Prior corneal refractive surgery. Macular or neuro-ophthalmic disease affecting visual function. Other ocular pathology expected to limit postoperative CDVA to worse than 20/30.
Inability to obtain reliable visual field testing when required for glaucoma characterization.
Intentional monovision. The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
PureSee EDOF IOL cohort
Subjects with bilateral implantation of the TECNIS PureSee Intraocular Lens (toric and non-toric) at cataract surgery. |
Bilateral implantation of the TECNIS PureSee non-diffractive extended depth of focus intraocular lens (toric and non-toric) at cataract surgery. |
|
TECNIS ZCB00 monofocal IOL cohort
Subjects with bilateral implantation of the TECNIS Monofocal Intraocular Lens ZCB00 (toric and non-toric) at cataract surgery. |
Bilateral implantation of the TECNIS Monofocal Intraocular Lens ZCB00 (toric and non-toric) at cataract surgery. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Distance visual acuity - binocular distance-corrected visual acuity (DCVA)
時間枠：3 to 18 months following second-eye cataract surgery
|
Binocular distance-corrected visual acuity measured at the single study visit occurring 3 to 18 months following second-eye cataract surgery. |
3 to 18 months following second-eye cataract surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Intermediate visual acuity - binocular distance-corrected intermediate visual acuity (DCIVA)
時間枠：3 to 18 months following second-eye cataract surgery
|
Binocular distance-corrected intermediate visual acuity at 66 cm measured at the single study visit occurring 3 to 18 months following second-eye cataract surgery. |
3 to 18 months following second-eye cataract surgery
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Contrast sensitivity - binocular, distance-corrected, photopic CSV-1000 contrast sensitivity without glare
時間枠：3 to 18 months following second-eye cataract surgery
|
CSV-1000 contrast sensitivity at spatial frequencies of 3, 6, 12, and 18 cycles per degree, binocular, distance-corrected, photopic, without glare. |
3 to 18 months following second-eye cataract surgery
|
|
Spectacle independence at distance, intermediate, and near
時間枠：3 to 18 months following second-eye cataract surgery
|
Patient-reported spectacle independence at distance, intermediate, and near. |
3 to 18 months following second-eye cataract surgery
|
|
Quality of vision and dysphotopsias
時間枠：3 to 18 months following second-eye cataract surgery
|
Patient-reported quality of vision and dysphotopsias assessed with validated patient-reported outcome instruments including the AIOLIS Questionnaire. |
3 to 18 months following second-eye cataract surgery
|
|
Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) Questionnaire
時間枠：3 to 18 months following second-eye cataract surgery
|
The AIOLIS has 37 questions about symptoms, perceptions of general vision, and frequency of wearing glasses or contact lenses. Perceptions about general vision are asked on a 5 item scale (Poor, Fair, Good, Very good, Excellent). Poor is considered a worse outcome. |
3 to 18 months following second-eye cataract surgery
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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