Effect of Minimizing Light Exposure Intensity on Macular Function After Cataract Surgery in Patients With Early or Intermediate AMD

NCT05988827 | Completed FDA Device

• 1 other identifier: 2023-A00815-40
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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 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

Conditions

Macular Degeneration, Age Related; Cataract

Keywords

Cataract, AMD, light exposure

Outcome Measures

Primary Outcomes (1)

• Assess the change from baseline of the retinal response amplitude in voltage in patients one hour after cataract surgery performed with NGenuity compared to standard light condition with SOM.

  The change from baseline of the photopic b-wave amplitude (µV) measured one hour after the cataract surgery by fERG.

  1 hour after cataract surgery

Secondary Outcomes (4)

• Assess the change from baseline in both arms of amplitude of the response in voltage in patients one day and one month after cataract surgery

  1 day and 1 month after cataract surgery

• Assess the change from baseline in both arms of latency of response in time in patients one hour, one day and one month after cataract surgery

  1 hour, 1 day and 1 month after cataract surgery

• Assess the change from baseline in both arms of total photoreceptors response in the macula one day and one month after cataract surgery

  1 day and 1 month after cataract surgery

• Assess the change from baseline in both arms of visual acuity one hour, one day and one month after cataract surgery.

  1 hour, 1 day and 1 month after cataract surgery

Study Arms (2)

NGenuity

EXPERIMENTAL

NGenuity allowing a reduced light intensity to 15% during cataract surgery

Device: NGenuity

SOM

NO INTERVENTION

microscope without NGenuity with light intensity of 60%, similar to a Standad Operating Microscope (SOM)

Interventions

NGenuity DEVICE

Cataract surgery performed under microscope using NGenuity

NGenuity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
• Pregnant or breastfeeding women
• Patient hospitalized without consent

Sponsors & Collaborators

• Elsan: lead
• Alcon Research: collaborator

Study Sites (1)

Hopital privé Guillaume de Varye

Saint-Doulchard, 18230, France

Location

MeSH Terms

Conditions

Macular Degeneration; Cataract

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Lens Diseases

Study Officials

• Otman Sandali, MD

  Hopital Prive Guillaume de Varye ELSAN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant is not aware about the light exposure used during the surgery (NGenuity or SOM)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, 2-arm controlled, parallel, single-masked, single-center study

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 14, 2023
• Study Start: September 14, 2023
• Primary Completion: July 10, 2024
• Study Completion: August 9, 2024
• Last Updated: September 3, 2024

Record last verified: 2024-08

Locations

FR (1)