Full Thickness Macular Hole and Internal Limiting Membrane Peeling Study

University of Aberdeen141 enrolled

Overview

A macular hole is a fairly common problem in the retina and is an important cause of loss of central vision. The aim of this study is to determine whether, in patients with a stage 2 or 3 full thickness macular hole (FTMH), peeling a very fine, transparent tissue that covers the surface of the retina, called the internal limiting membrane (ILM) during surgery is superior to non-ILM peeling macular hole surgery. The main outcomes are improvement in vision, achievement of macular hole closure, need for re-operation, health related quality of life (HRQOL) and cost effectiveness.

Idiopathic full-thickness macular hole (FTMH) is an important cause of loss of central vision, usually leading to severe visual impairment. Up to 20% of affected people will develop a FTMH in both eyes. There is uncertainty in the literature and among vitreo-retinal surgeons about the balance of potential benefits and adverse effects of ILM peeling in FTMH surgery for stage 2-3 holes. FILMS is a randomised controlled trial (RCT) in patients with stage 2-3 FTMH less less than 18 months duration investigating whether ILM peeling improves the anatomical and visual outcome of macular hole surgery and the quality of life of patients with this retinal disease. Cost-effectiveness is also being addressed.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

141

Conditions

Stage 2 or 3 Full Thickness Macular Hole

Interventions

Vitrectomy, post hyaloid detachment and gas injection with or without ILM peel.PROCEDURE

Combined cataract surgery (phacoemulsification and intraocular lens implantation) and pars plana vitrectomy with postoperative intraocular tamponade with gas, with or without ILM peeling

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Idiopathic FTMH of stage 2-3, Duration of hole ≤18 months, Visual acuity equal to or worse than 20/40 in the study eye. Exclusion Criteria: Stage 1 or 4 FTMH, Stage 2-3 FTMH of \> 18 months duration, Visual acuity \>20/40 in study eye, FTMH related to high myopia (\>6 dioptres), FTMH related to trauma, any other causes of decreased vision (ie corneal scarring, age-related macular degeneration, diabetic retinopathy, glaucoma if central and/or paracentral absolute visual field defects present), patient unable to understand English, patient unable to give informed consent.

Locations (9)

Royal Victoria Eye and Ear Hospital

Dublin, Ireland

Waterford Regional Hospital

Waterford, Ireland

Aberdeen Royal Infirmary

Aberdeen, United Kingdom

Bristol Eye Hospital

Bristol, United Kingdom

Outcomes

Primary Outcomes

The primary outcome of the study is the mean difference between treatment groups in the Early Treatment Diabetic Retinopathy Study (ETDRS) distance visual acuity score.

Time frame: 6 months post surgery

Secondary Outcomes

Secondary outcomes include anatomical closure, adverse events, re-operation, distance visual acuity (VA), near VA, contrast sensitivity, reading speed, costs to the health service and the participant and HRQOL.

Time frame: 3, 6 and 24 months post surgery

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.