Comparison of Two Intraocular Gas Injection Techniques in Macula Hole Surgery

Phase 4

Completed

• Conditions: Macular Holes
• Interventions: Drug: small amount of undiluted C3F8

• Registration Number: NCT04527848
• Lead Sponsor: Universidade Federal de Pernambuco

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-10
• Primary Completion: 2020-07-31
• Study Completion: 2020-07-31
• Study First Submitted: 2020-08-23
• Study First Submitted QC: 2020-08-23
• Study First Posted: 2020-08-27
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-07
• Last Update Posted: 2020-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
large amount of diluted SF6	small amount of undiluted C3F8	-
small amount of undiluted C3F8	small amount of undiluted C3F8	-
large amount of diluted C3f8	small amount of undiluted C3F8	-
small amount of undiluted SF6	small amount of undiluted C3F8	-

Primary Outcome Measures

Name	Time	Method
macula hole closure	26 weeks	closure of the macular hole after the primary surgical procedure
Gas duration	up to 60 days	duration of intraocular gas

Secondary Outcome Measures

Name	Time	Method
visual acuity	preoperative, 26 weeks	corrected distance visual acuity
intraocular pressure	preoperative, 1 day, 26 weeks	intraocular pressure

Trial Locations

Locations (1)

UFPE Ophthalmology; 🇧🇷 Recife, PE, Brazil