Comparison of Two Intraocular Gas Injection Techniques in Macula Hole Surgery

Universidade Federal de Pernambuco

Status and phase: Completed; Phase 4

Conditions: Macular Holes

Treatments: Drug: small amount of undiluted C3F8

Study type: Interventional

Funder types: Other

Identifiers

NCT04527848

12347319.9.0000.8807

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 4 patient groups

small amount of undiluted C3F8

Experimental group

Treatment:

Drug: small amount of undiluted C3F8

large amount of diluted C3f8

Active Comparator group

Treatment:

Drug: small amount of undiluted C3F8

small amount of undiluted SF6

Active Comparator group

Treatment:

Drug: small amount of undiluted C3F8

large amount of diluted SF6

Active Comparator group

Treatment:

Drug: small amount of undiluted C3F8