NCT05988827Completed
Effect of Minimizing Light Exposure Intensity on Macular Function After Cataract Surgery in Patients With Early or Intermediate AMD
Effect of Minimizing Light Exposure Intensity of 3D Digital Visualization (NGenuity) on Macular Function After Cataract Surgery in Patients With Early or Intermediate AMD: A Comparative ERG
Source: ClinicalTrials.gov · Last updated 3 Sept 2024
Brief summary (registry, in English)
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 even in short procedures; however, this potential toxicity has not been evaluated by objective criteria. Indeed, this retinal phototoxicity would be increased for patients with mild macular diseases such as early stages of AMD (Aged Macular Degeneration) (ie: drusen) which are frequently associated in elderly patients with cataract. The aim of the study will be to assess the potential functional macular effects by focal and multifocal ERG after cataract surgery with NGenuity by comparison to Standard Operating Microscope (SOM). This study would particularly address eyes at risk for macular toxicity like patients with early or intermediate AMD
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 42 (actual)
- First submitted
- 3 Aug 2023
- Start date
- 14 Sept 2023
- Primary completion date
- 10 Jul 2024
- Lead sponsor
- Elsan
- Diseases
- Macular degeneration
- NCT number
- NCT05988827
What you commit to
- Study type: Interventional
- Participants enrolled: 42
- From 14 Sept 2023 to the primary completion date, 10 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- AMD defined by geographic atrophy or pigment epithelium detachment, subretinal hemorrhage or visible subretinal new vessel, or subretinal fibrous scars 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
Age
- Children under 18 years old
- Non-age-related cataracts
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital privé Guillaume de Varye Coordinator of this site? Confirm its status | Saint-Doulchard | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.