Status:
COMPLETED
Effect of Minimizing Light Exposure Intensity on Macular Function After Cataract Surgery in Patients With Early or Intermediate AMD
Lead Sponsor:
Elsan
Collaborating Sponsors:
Alcon Research
Conditions:
Macular Degeneration, Age Related
Cataract
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Cataract surgery is one of the most frequently performed surgical interventions worldwide. The microscope light-induced retinal toxicity after cataract surgery has been described in several reports ev...
Detailed Description
Cataract surgery is one of the most frequently performed surgical interventions worldwide. The development of phacoemulsification technology, instrumentation and surgical techniques has improved both ...
Eligibility Criteria
Inclusion
- Patient undergoing cataract surgery and presenting signs of early AMD with medium-sized drusen (between 63 µm and 125 µm in diameter) or intermediate AMD with large drusen (\>125 µm) or pigmentary abnormalities with at least medium sized drusen in the study eye.
- Patient affiliated to health care system
- Patient with signed informed consent
Exclusion
- Children under 18 years old
- AMD defined by geographic atrophy or pigment epithelium detachment, subretinal hemorrhage or visible subretinal new vessel, or subretinal fibrous scars in the study eye
- Non-age-related cataracts
- History of previous ocular surgery, anterior segment (corneal, anterior chamber, sulcus) or posterior segment (uveal, vitreo-retinal) pathology including retinal vascular occlusive disease, retinal detachment or peripheral retinal laser photocoagulation, neovascular AMD, glaucoma in the study eye
- Any current anterior or posterior segment inflammation of any etiology, and/or history of any disease producing an intraocular inflammatory reaction.
- Patient with conditions that increase the risk of zonular rupture during cataract extraction procedure that may affect the postoperative centration or tilt of the IOL
- Patient treated by plaquenil
- Patient already enrolled in the same study for one eye
- Patient already enrolled in clinical trial or with exclusion period in progress
- Patient under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- Pregnant or breastfeeding women
- Patient hospitalized without consent
Key Trial Info
Start Date :
September 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2024
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT05988827
Start Date
September 14 2023
End Date
August 9 2024
Last Update
September 3 2024
Active Locations (1)
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1
Hopital privé Guillaume de Varye
Saint-Doulchard, France, 18230