Clinical trial NCT03329976: Validation of a Prognostic Score for Good Visual Recovery at One Year Following Combined Surgery for Cataract and Idiopathic Epiretinal Membrane
Official title: Validation of a Prognostic Score for Good Visual Recovery at One Year Following Combined Surgery for Cataract and Idiopathic Epiretinal Membrane
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgery for Cataract
Surgery for and Idiopathic Epiretinal Membrane
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 450
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: any person about to undergo combined surgery for cataract and ERM

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Patients presenting idiopathic ERM visible on SD-OCT;
* Indication for combined cataract and ERM surgery in a context of a fall in visual acuity or disabling metamorphopsia;
* Patients who have provided verbal consent;
* Age ≥ 40 years.

Exclusion Criteria:

* Patients with secondary ERM (Diabetes WITH a history of diabetic retinopathy or maculopathy, occlusion of the retinal veins, uveitis intermediate/posterior uveitis or retinal tear/detachment in the studied eye;
* Patient présentant toute autre maculopathie ou neuropathie optique ;
* Patient presenting severe myopia (spherical equivalent ≥ 6 diopters or axial length ≥ 26 mm) ;
* Patients presenting any other ophthalmological disease independent of the ERM and likely to limit visual acuity
* Patients who have already undergone vitrectomy in the studied eye;
* Non-visible or poorly visible fundus due to a cloudy vitreous (Signal on OCT Cirrus \<5, Quality score on OCT Spectralis \< 20, signal trend index on OCT Optovue \< 30)
* Patients without national health insurance cover
* Pregnant or breast-feeding women.

Primary outcomes:
measure: scale of monoyer at 5 meter
timeFrame: over the 12 months of follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References: