Epiretinal Fibrosis, Effect of Early Surgery (epitell)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Glostrup University Hospital, Copenhagen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT00902629
First received: May 13, 2009
Last updated: May 25, 2010
Last verified: May 2009
  Purpose

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.


Condition Intervention
Epiretinal Membrane
Procedure: Early surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial Investigating the Longterm Results of Early vs. Delayed Surgery for Epiretinal Fibrosis.

Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • Change in best corrected visual acuity, 12 months after enrollment [ Time Frame: 12 months after enrollment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Retinal morphology in the control cohort, 12 months after enrollment [ Time Frame: 12 months after enrollement ] [ Designated as safety issue: No ]
  • Change in subjective quality of life 12 month after enrollment. [ Time Frame: 12 months after enrollment ] [ Designated as safety issue: No ]
  • Changes in visual field 12 months after enrollment [ Time Frame: 12 months after enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2008
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00902629

Contacts
Contact: Mads Kofod, MD +454323 4819 mads@kofod.tv

Locations
Denmark
Eye department, Glostrup University hospital Recruiting
Glostrup, Copenhagen, Denmark, 2600
Contact: Mads Kofod, MD    +454323 4819    mads@kofod.tv   
Principal Investigator: Mads Kofod, MD         
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Investigators
Principal Investigator: Mads Kofod, MD Eye department, Glostrup University Hospital
  More Information

No publications provided

Responsible Party: Mads Kofod, Faculty of healthscience, University of Copenhagen
ClinicalTrials.gov Identifier: NCT00902629     History of Changes
Other Study ID Numbers: EPITELL
Study First Received: May 13, 2009
Last Updated: May 25, 2010
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Glostrup University Hospital, Copenhagen:
Epiretinal Fibrosis
Macular Pucker

Additional relevant MeSH terms:
Fibrosis
Epiretinal Membrane
Pathologic Processes
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 16, 2014