'Distortion as a Predictor of ERM Surgery Outcome'

March 9, 2021 updated by: NHS Greater Glasgow and Clyde

Does Pre-operative D-chart Score Predict Improvement in VFQ-25 Score Following Surgery for Epiretinal Membrane?

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Epiretinal membranes consist of a proliferation of fibrocellular tissue along the inner aspect of the retina. Over time, this membrane can result in anterior-posterior traction and cause disruption of the retinal architecture, which can lead to symptoms of blurred vision, or distorted vision (with straight lines appearing bent or wavy).

Patients with ERM now constitute one of the most common referrals to the vitreoretinal service. Management of epiretinal membrane includes observation or surgery for severely symptomatic membranes. The surgery consists of vitrectomy and epiretinal +/- inner limiting membrane peel. Currently there is limited evidence to help identify which patients with an epiretinal membrane are the most likely to benefit from this operation, which makes it more difficult for patients to be able to weigh up the benefits and risks of proceeding with this elective procedure.

Our study will measure the effects on distortion (using D chart), visual acuity and quality of life of ERM surgery. Hence it will allow us to investigate whether the pre-op D chart score can predict subsequent improvement in quality of life following surgery. This will provide vitreoretinal surgeons and patients with an evidence base regarding the success of this elective procedure and offer realistic expectations regarding surgical outcomes. Ultimately, we hope that the results of this study will facilitate the decision of whether or not to proceed with ERM surgery.

We plan to recruit patients with an epiretinal membrane who choose to undergo surgery at the time of their clinic appointment within the vitreoretinal service. In addition to standard care, the study participants will undergo measurements of distortion (using a D-chart, duration 5-10 minutes) and fill in a quality of life questionnaire. These measurements will be taken before the operation and at six and twelve months following the operation.

The aims of the study are:

  • To investigate the sustained effect of epiretinal membrane surgery on distortion (using D-chart), visual acuity and vision-related quality of life (using NEI VFQ-25 questionnaire)
  • To determine the relationship between pre-operative distortion score and post-operative vision-related quality of life score following ERM surgery

Our study will have a larger number of participants with a longer period of follow up (52 weeks) than comparable studies. It will be the first epiretinal membrane study that measures distortion using the D-chart, which we believe to be superior to existing tests (such as the M-chart) which have been used in similar studies.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Paisley, United Kingdom, PA2 7DE
        • NHS Greater Glasgow and Clyde Clinical Research and Development Central Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with epiretinal membranes attending the vitreoretinal clinic at the Tennent Institute of Ophthalmology in Glasgow, UK, and meeting the inclusion criteria.

Description

Inclusion Criteria:

  1. Idiopathic epiretinal membrane
  2. Patients undergoing vitrectomy and gas surgery, under local or general anaesthetic
  3. Able to give informed consent
  4. 18 years old and over

Exclusion Criteria:

  1. Epiretinal membrane secondary to retinal detachment, uveitis or retinal vascular disease
  2. Previous vitreoretinal surgery
  3. Pre-existing ophthalmic condition which limits the patient's visual acuity (Documented BCVA 6/36 or worse)
  4. Pre-existing ophthalmic conditions which cause metamorphopsia (exudative ARMD, central serous retinopathy)
  5. VA < 6/60

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VFQ-25 score at final visit (52 weeks after ERM surgery)
Time Frame: 1 year
Measure of vision-related quality of life using NEI VFQ-25 quality of life questionnaire, 1 year after surgery for epiretinal membrane
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distortion score pre-operatively and at 26 and 52 weeks after ERM surgery
Time Frame: 1 year
Distortion score calculated using D-chart
1 year
Best-corrected visual acuity pre-operatively and at 26 and 52 weeks after ERM surgery
Time Frame: 1 year
Visual acuity measured in ETDRS
1 year
Vision-related quality of life pre-operatively and at 26 and 52 weeks after ERM surgery
Time Frame: 1 year
Vision-related quality of life assessed using NEI VFQ-25 quality of life questionnaire
1 year
Central retinal thickness pre-operatively and at 26 and 52 weeks after ERM surgery
Time Frame: 1 year
Central retinal thickness obtained from OCT scans done in clinic
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Greater Glasgow and Clyde

Collaborators

Royal College of Surgeons of Edinburgh

Investigators

  • Principal Investigator: Lona Jawaheer, MBChB, NHS Greater Glasgow and Clyde
  • Principal Investigator: David Yorston, MBChb, NHS Greater Glasgow and Clyde

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 1, 2021

Primary Completion (ANTICIPATED)

April 1, 2023

Study Completion (ANTICIPATED)

April 1, 2023

Study Registration Dates

First Submitted

February 9, 2021

First Submitted That Met QC Criteria

March 9, 2021

First Posted (ACTUAL)

March 10, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GN18OP439

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Quality of Life

Clinical Trials on Epiretinal membrane surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe