Epiretinal Fibrosis, Effect of Early Surgery (epitell)

August 10, 2015 updated by: Mads Kofod, Glostrup University Hospital, Copenhagen

Randomized Clinical Trial Investigating the Longterm Results of Early vs. Delayed Surgery for Epiretinal Fibrosis.

The goal of this randomized clinical trial is to investigate when it is optimal to treat the eye disease epiretinal fibrosis.

Hypothesis: In a population of patients with symptomatic idiopathic epiretinal fibrosis and visual acuity above 0.4, the best long term outcome measured by visual acuity is achieved by early surgery compared to periodic controls until a continual loss of visual acuity has been ensure followed by surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Epiretinal fibrosis is a disease of the macula, which affects the central retina, and there by the central vision. Epiretinal fibrosis is due to a growth of connective tissue on retinas surface.

From population studies shows that 15% of patients with epiretinal fibrosis will develop moderate to severe loss of visual acuity. Earlier studies have shown that surgery to remove the epiretinal membrane most often leads to improvements in visual acuity if not a normalization of this. The reason why not everyone has normalization of their visual acuity could be growth of connective in the deeper layers of the retina. This intraretinal fibrosis develops over time and is presumed to worsen with the duration of the condition.

In a patient with symptomatic epiretinal fibrosis and visual acuity over 0,4, the current clinical practice is to utilize the wait and see approach, where you hold of treatment until you have made sure that the patients visual acuity is declining. With the wait and see approach you avoid doing surgery on eyes that would have remained stable in their visual acuity. On the other hand will the same approach always ensure that we do surgery on eye that have deteriorated visual acuity, usually to a point of 0,1-0,3 and longer duration of disease.

Hence the results of delayed surgery are presumably worse than what could have been achieved by operating at an earlier point.

This project aims to investigate if you can give the patients a more favorable long term result by doing surgery earlier compared to the traditional wait and see approach.

This study is a prospective randomized clinical trial. We aim to include 60 patients, where 20 will be randomized to early surgery (intervention) and 40 to a close follow-up program(control). If the patients in the control group loss more than 10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters during the follow-up of of they request surgery for their epiretinal fibrosis they will be offered the same operation as the intervention group.

The Intervention group is to have clear lens extraction if they are not already operated for cataract. This is within 4 weeks of inclusion, and another 4 weeks after this they will have their epiretinal fibrosis removed by pars plana vitrectomy.

There are clinical controls after 3,6,9 and 12 months after inclusion/surgery for both groups.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Denmark
    • Copenhagen
      • Glostrup, Copenhagen, Denmark, 2600
        • Eye department, Glostrup University hospital

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

Description

Inclusion Criteria:

  • Subjective loss of visual acuity and/or visual distortions
  • Visual acuity more than or equal to 35 ETDRS letters (at 4 meter)
  • Duration of symptoms Less than 13 months
  • Metamorphopsia on a Amsler Grid
  • Binocular vision disturbed

Exclusion Criteria:

  • Diabetic eye symptoms
  • Previous oculary surgery, except cataract
  • Presence of hard drusen in age-related macular degeneration (AMD)
  • Other serious eye diseases
  • Patients unable to complete the follow up
  • not legal guardian of themselves

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Intervention group contains the patients randomized for early treatment of their epiretinal fibrosis.
Procedure: Early surgery
Intervention group contains patients randomized to receive surgery for their epiretinal fibrosis, at an earlier point than what the common clinical practice is now.
No Intervention: Control
Control contains patients not randomized for early surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in best corrected visual acuity, 12 months after enrollment
Time Frame: 12 months after enrollment
12 months after enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
Retinal morphology in the control cohort, 12 months after enrollment
Time Frame: 12 months after enrollement
12 months after enrollement
Change in subjective quality of life 12 month after enrollment.
Time Frame: 12 months after enrollment
12 months after enrollment
Changes in visual field 12 months after enrollment
Time Frame: 12 months after enrollment
12 months after enrollment

Collaborators and Investigators

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

Sponsor

Glostrup University Hospital, Copenhagen

Investigators

  • Principal Investigator: Mads Kofod, MD, Eye department, Glostrup University hospital

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

May 1, 2008

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

May 13, 2009

First Submitted That Met QC Criteria

May 14, 2009

First Posted (Estimate)

May 15, 2009

Study Record Updates

Last Update Posted (Estimate)

August 13, 2015

Last Update Submitted That Met QC Criteria

August 10, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPITELL

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.

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