Image

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

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

Recruiting
40 years and older
All
Phase N/A

Powered by AI

Overview

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

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.

Study details
    Surgery for Cataract
    Surgery for and Idiopathic Epiretinal Membrane

NCT03329976

Centre Hospitalier Universitaire Dijon

18 April 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.