Comparison of Two Intraocular Gas Injection Techniques in Macula Hole Surgery

Universidade Federal de Pernambuco48 enrolled

Overview

To undertake a prospective randomized clinical trial of vitrectomy and gas tamponade to treat macular hole, utilizing a small amount of undiluted C3F8 (perfluoropropane) versus a large amount of diluted C3F8 versus a small amount of undiluted SF6 (sulfur hexafluoride) versus a large amount of diluted SF6.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Macular Holes

Interventions

small amount of undiluted C3F8DRUG

vitrectomy followed by peeling of the internal limiting membrane and, after that, intraocular gas injection

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * pseudophakia * without previous vitreoretinal surgery * diagnosed with a full-thickness macula hole on the optical coherence tomography exam. * duration of symptoms less than 6 months * inform consent Exclusion Criteria: * ocular trauma * allergy to any of the products used in the study, * need to travel by plane in the first 60 postoperative days * myopia over 6 diopters or axial diameter over 26 mm * retinal dystrophies * retinal detachment * abnormal eye shape * glaucoma * diabetic retinopathy or other eye comorbidities.

Locations (1)

UFPE Ophthalmology

Recife, Pernambuco, Brazil

Outcomes

Primary Outcomes

Gas duration

duration of intraocular gas

Time frame: up to 60 days

macula hole closure

closure of the macular hole after the primary surgical procedure

Time frame: 26 weeks

Secondary Outcomes

visual acuity

corrected distance visual acuity

Time frame: preoperative, 26 weeks

intraocular pressure

Time frame: preoperative, 1 day, 26 weeks

Data from ClinicalTrials.gov

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