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Epiretinal Fibrosis, Effect of Early Surgery (epitell)

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ClinicalTrials.gov Identifier: NCT00902629
Recruitment Status : Completed
First Posted : May 15, 2009
Last Update Posted : August 13, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Epiretinal Membrane Procedure: 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 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial Investigating the Longterm Results of Early vs. Delayed Surgery for Epiretinal Fibrosis.
Study Start Date : May 2008
Primary Completion Date : February 2015
Study Completion Date : February 2015
Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. Change in best corrected visual acuity, 12 months after enrollment [ Time Frame: 12 months after enrollment ]

Secondary Outcome Measures :
  1. Retinal morphology in the control cohort, 12 months after enrollment [ Time Frame: 12 months after enrollement ]
  2. Change in subjective quality of life 12 month after enrollment. [ Time Frame: 12 months after enrollment ]
  3. Changes in visual field 12 months after enrollment [ Time Frame: 12 months after enrollment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00902629


Locations
Denmark
Eye department, Glostrup University hospital
Glostrup, Copenhagen, Denmark, 2600
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Investigators
Principal Investigator: Mads Kofod, MD Eye department, Glostrup University Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mads Kofod, Md, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT00902629     History of Changes
Other Study ID Numbers: EPITELL
First Posted: May 15, 2009    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015

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

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