Quality of Vision After Implantation of EDOF Implants Versus Monofocal Implants in Patients Who Underwent Epiretinal Membrane and Cataract Surgery (MACAEDOF)
A Prospective, Randomized Study Evaluating the Quality of Vision After Implantation of EDOF Implants Versus Monofocal Implants in Patients Who Underwent Epiretinal Membrane and Cataract Surgery
Phacoexistence, the first surgical procedure performed in France, naturally raises the question of lens replacement. In recent years, the choice of intraocular lenses has expanded considerably. The term EDOF (Extended Depth of Focus) refers to intraocular lenses offering an extended depth of field to improve vision at different distances, while reducing the visual aberrations associated with traditional multifocal lenses.
However, they still generate some optical aberrations that could therefore limit the quality of vision for patients with retinal damage.
With the development and acceleration of cataractogenic processes observed after vitrectomy, the use of combined phaco-vitrectomy surgery has become increasingly common, particularly among patients over 60 years of age. This integrated approach allows for the simultaneous treatment of cataracts and vitreoretinal pathologies, thus reducing the need for subsequent cataract surgery, which frequently develops after vitrectomy. In addition to optimizing the patient care pathway, this technique offers clinical advantages, such as faster visual recovery and fewer complications associated with multiple surgeries. Phacovitrectomy is therefore emerging as a practical and effective solution for managing elderly patients requiring vitreoretinal surgery.
Therefore, in the specific context of macular surgery, often considered less suitable for the use of premium implants, EDOF (Extended Depth of Focus) implants raise some questions. The available data on their performance and tolerability in this specific context remain limited, making their use still poorly defined in these complex clinical situations, except in certain medical macular pathologies.4 This study aims to evaluate, within the context of macular surgery, the relevance and potential role of EDOF (Extended Depth of Focus) implants in order to improve the management of these patients.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Jessica Delorme
- 电话号码：00336 23 91 95 73
- 邮箱：jessica.delorme@almaviva-sante.com
学习地点
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Aix-en-Provence、法国、13097
- Clinique du Val d'Ouest - Centre Pôle Vision
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接触：
- Sébastien Guigou
- 电话号码：0033442992150
- 邮箱：rdv@aixvision.fr
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Marseille、法国、13008
- Centre Monticelli Paradis
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接触：
- Frédéric MATONTI, Dr
- 电话号码：00336 23 86 69 46
- 邮箱：frederic.matonti@free.fr
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Écully、法国、69130
- Clinique du Val d'Ouest - Centre Pôle Vision
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接触：
- Pierre-Loïc Cornut
- 电话号码：0033478356969
- 邮箱：jessica.delorme@almaviva-sante.com
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Male or female over 18 years of age
- Epiretinal membrane with surgical indication
- Indication for cataract surgery with intraocular lens implantation
- Epiretinal membranes with near visual acuity ≥ P4
- Preserved ellipsoidal zone in the retrofoveal region, without fragmentation or interruption
- Central macular thickness less than or equal to 450 microns
- Signed informed consent
- Patients covered by social security or an equivalent scheme
Exclusion Criteria:
- Associated ocular pathologies (advanced glaucoma, exudative AMD).
- Central macular thickness > 450 microns
- Epiretinal membranes with near visual acuity < P4
- Previous macular surgery
- Contraindication to the implantation of either type of lens
- Cognitive impairment, or a disorder causing difficulty understanding instructions or answering questionnaires
- Pregnant, parturient, or breastfeeding women, as defined in Article L1121-5 of the French Public Health Code (CSP)
- Protected individuals: adults under guardianship, curatorship, or other legal protection, deprived of liberty by judicial or administrative decision.
- Patients incapable of personally giving consent, as defined in Article L.1121-8 of the French Public Health Code (CSP), or adults protected by law
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Implants EDOF
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NEI-VFQ (National Eye Institute Visual Function Questionnaire) 25 before the surgery, 3 months after and 6 months after the surgery.
ETDRS (Early Treatment Diabetic Retinopathy Study) scale before the surgery and 1 month, 3 months and 6 months after the surgery
1 month, 3 months and 6 months after surgery
Two different cataract surgeries : TECNIS monofocal versus PureSee EDOF (extended depth of focus)
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有源比较器：Monofocal implants
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NEI-VFQ (National Eye Institute Visual Function Questionnaire) 25 before the surgery, 3 months after and 6 months after the surgery.
ETDRS (Early Treatment Diabetic Retinopathy Study) scale before the surgery and 1 month, 3 months and 6 months after the surgery
1 month, 3 months and 6 months after surgery
Two different cataract surgeries : TECNIS monofocal versus PureSee EDOF (extended depth of focus)
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Distance visual acuity (4 m)
大体时间：3 months
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Distance visual acuity (4 m) using the ETDRS (Early Treatment Diabetic Retinopathy Study) scale at 3 months. This involves asking the patient, positioned 4 meters away, to read a chart made up of 5 letters per line, with the size gradually decreasing from top to bottom. The score is determined by counting the number of letters read correctly (each letter is worth 1 point). The maximum score is 100 to 110 letters depending on the version. |
3 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
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首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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