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'Distortion as a Predictor of ERM Surgery Outcome'

NCT04791631 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2021-03-10

No results posted yet for this study

Summary

Epiretinal membranes (ERM) consist of an abnormal growth of tissue across the retina and are present about 6% of people aged 50 and over. They can cause symptoms of distortion (straight lines appearing bent) or blurred vision. Management options include observation if asymptomatic, or surgery to peel the membrane if symptomatic. Limited data exists regarding how to identify patients who are most likely to benefit from surgery.

We propose to measure the effects on distortion (using D chart), visual acuity and vision-related quality of life (using a validated vision-related quality of life questionnaire) of ERM surgery. This will allow us to investigate whether pre-operative D chart score can predict subsequent improvement in quality of life following surgery. We hope the results will help patients and VR surgeons decide whether or not to proceed with ERM surgery.

The study will be a prospective case series consisting of patients with symptomatic epiretinal membranes who choose to have epiretinal membrane surgery. The study participants will get standard care with the additional administration of a quality of life questionnaire and measurement of distortion (using a D-chart) at 3 different time points (pre-op, and post-op at 26 and 52 weeks). Recruitment will be in Glasgow, with a possibility of other sites being added on at a later stage.

Conditions

  • Epiretinal Membrane
  • Distortion
  • Quality of Life

Interventions

PROCEDURE

Epiretinal membrane surgery

Surgery for epiretinal membrane i.e. standard 3-port pars plana vitrectomy and epiretinal membrane and internal limiting membrane peel. Phakic patients will undergo cataract surgery.

Sponsors & Collaborators

  • Royal College of Surgeons of Edinburgh

    collaborator OTHER

  • NHS Greater Glasgow and Clyde

    lead OTHER

Principal Investigators

  • Lona Jawaheer, MBChB · NHS Greater Glasgow and Clyde

  • David Yorston, MBChb · NHS Greater Glasgow and Clyde

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2023-04-01
Completion
2023-04-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04791631 on ClinicalTrials.gov