Clinical Trials Directory

Trials / Terminated

TerminatedNCT03329976

Validation of a Prognostic Score for Good Visual Recovery at One Year Following Combined Surgery for Cataract and Idiopathic Epiretinal Membrane

Status
Terminated
Phase
Study type
Observational
Enrollment
164 (actual)
Sponsor
Centre Hospitalier Universitaire Dijon · Academic / Other
Sex
All
Age
40 Years
Healthy volunteers
Not accepted

Summary

The prevalence of idiopathic epiretinal membranes (ERM) in people over 50 is estimated at 6 to 19%. Even though most cases show very few symptomats, they may induce alterations of the underlying retina and lead to visual impairment likely to greatly diminish quality of life in patients. Thanks to the ever-improving quality of vitreo-retinal surgery, ablation of these membranes is a frequent and safe procedure allowing a functional gain in the majority of cases. Given the increasing prevalence in the population concerned and the accelerated ageing of the lens after vitrectomy, cataract surgery is often associated with removal of the membrane. On the basis of a study in 142 patients, it was possible to identify clinical and morphological prognostic factors and to inclure them in a score to assess the chances of complete functional recovery at one year following the procedure . Age of the patient, the duration of symptoms, initial visual acuity and the quality of the junction between external and internal segments of photoreceptors in optic coherence tomography (OCT) appeared as significantly related to visual results. Using this score in a new prospective cohort would allow the investigators to make it a reliable and easy-to-use tool at the service of ophthalmologist surgeons and their patients and would provide scientific confirmation of the interest of earlier surgery in this disease. It would also allow the investigators to define in a validated and reproducible manner, a threshold for an ndication for ERM surgery, which is currently based on relatively subjective criteria mostly related to visual acuity.

Conditions

Interventions

TypeNameDescription
OTHERmeasurement of visual acuitycomplete ophthalmologic examination of a macular SD-OCT, a fundus of eye, evaluation of the vision of contrasts (Pelli-Robson test) and quantification of metamorphopsies (M-Charts);

Timeline

Start date
2018-04-03
Primary completion
2026-01-05
Completion
2026-01-05
First posted
2017-11-06
Last updated
2026-02-04

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03329976. Inclusion in this directory is not an endorsement.