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

Elsan

Status

Completed

Conditions

Cataract

Macular Degeneration, Age Related

Treatments

Device: NGenuity

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05988827

2023-A00815-40

Details and patient eligibility

About

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

Full 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 the efficacy and safety of procedures, reducing rates of serious postoperative adverse events. 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. A systematic literature review of 129 664 individuals estimated the prevalence of early macular degeneration to 8.01% in population aged 45 to 85 years. A three-dimensional (3D) heads-up system (NGenuity®, Alcon, Fort Worth, TX) was recently introduced for both vitreoretinal and cataract surgery, radically improving the quality of surgical visualization. This system allows performing cataract surgery at a lower fraction of light intensity reducing patient's photophobia complaints during surgery and probably preventing potential phototoxic macular injury in cataract surgery. In a recent pilot study, the Ngenuity system was reported to decrease significantly the operative light intensity and to contribute to a faster visual recovery relative to traditional microscopes in series of 35 patients (51 eyes) who underwent cataract surgery. 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 AMD: medium-sized drusen (between 63µm and 125µm in diameter) without pigmentary abnormalities
with intermediate AMD : large drusen (>125 µm) or pigmentary abnormalities in the retina associated with at least medium drusen

Enrollment

42 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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