Epiretinal Fibrosis, Effect of Early Surgery
epitell
Randomized Clinical Trial Investigating the Longterm Results of Early vs. Delayed Surgery for Epiretinal Fibrosis.
1 other identifier
interventional
56
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 13, 2009
CompletedFirst Posted
Study publicly available on registry
May 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedAugust 13, 2015
August 1, 2015
6.8 years
May 13, 2009
August 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in best corrected visual acuity, 12 months after enrollment
12 months after enrollment
Secondary Outcomes (3)
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 Arms (2)
Intervention
EXPERIMENTALIntervention group contains the patients randomized for early treatment of their epiretinal fibrosis.
Control
NO INTERVENTIONControl contains patients not randomized for early surgery.
Interventions
Intervention group contains patients randomized to receive surgery for their epiretinal fibrosis, at an earlier point than what the common clinical practice is now.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eye department, Glostrup University hospital
Glostrup Municipality, Copenhagen, 2600, Denmark
Related Publications (1)
Kofod M, Christensen UC, la Cour M. Deferral of surgery for epiretinal membranes: Is it safe? Results of a randomised controlled trial. Br J Ophthalmol. 2016 May;100(5):688-92. doi: 10.1136/bjophthalmol-2015-307301. Epub 2015 Sep 16.
PMID: 26377411DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mads Kofod, MD
Eye department, Glostrup University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Md
Study Record Dates
First Submitted
May 13, 2009
First Posted
May 15, 2009
Study Start
May 1, 2008
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
August 13, 2015
Record last verified: 2015-08