Skip to main content
Clinical Trials/NCT00902629
NCT00902629
Completed
N/A

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

Glostrup University Hospital, Copenhagen1 site in 1 country56 target enrollmentMay 2008

Overview

Phase
N/A
Intervention
Not specified
Conditions
Epiretinal Membrane
Sponsor
Glostrup University Hospital, Copenhagen
Enrollment
56
Locations
1
Primary Endpoint
Change in best corrected visual acuity, 12 months after enrollment
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
May 2008
End Date
February 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Glostrup University Hospital, Copenhagen
Responsible Party
Principal Investigator
Principal Investigator

Mads Kofod

Md

Glostrup University Hospital, Copenhagen

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in best corrected visual acuity, 12 months after enrollment

Time Frame: 12 months after enrollment

Secondary Outcomes

  • Retinal morphology in the control cohort, 12 months after enrollment(12 months after enrollement)
  • Change in subjective quality of life 12 month after enrollment.(12 months after enrollment)
  • Changes in visual field 12 months after enrollment(12 months after enrollment)

Study Sites (1)

Loading locations...

Similar Trials