Small Macular Holes Treated With Air

N/ARecruitingNCT06211907

Helse Stavanger HF132 enrolled

Overview

Non-inferiority trial comparing intraocular air and gas tamponade for closure of macular holes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

132

Conditions

Macular Holes

Interventions

Postoperative intraocular tamponadeDEVICE

Flushing the eye cavity with a tamponade at the end of surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Primary MH ≤250 μm * MH duration ≤12 months * No previous vitreoretinal surgery in study eye * Ability to sign informed consent * Signed informed consent * Age ˃18 years Exclusion Criteria: * Previous vitreoretinal surgery in study eye * Secondary MH caused by other conditions than vitreomacular traction * Myopic MH, i.e., excessive myopia (more than -6 dioptres) * Traumatic MH * MH secondary to retinal detachment or other retinal diseases * Previously participation in this study

Locations (7)

Department of Ophthalmology, University of Thessaly

Thessaly, Thessaly, Greece

NOT_YET_RECRUITING

Stavanger University Hospital

Stavanger, Rogaland, Norway

RECRUITING

University Hospital of Northern Norway

Tromsø, Troms, Norway

Outcomes

Primary Outcomes

Macular hole closure after single surgery

Closure verified on OCT

Time frame: 4 weeks

Secondary Outcomes

Change in outcome of patient well-being

Questionnaire

Time frame: 4 weeks and 4 months

Change in visual acuity i ETDRS lines

Early Treatment of Diabetic Retinopathy Score in logMAR. Higher scores mean a worse outcome

Time frame: 4 weeks and 4 months

Data from ClinicalTrials.gov

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