Comparison of Two Intraocular Gas Injection Techniques in Macula Hole Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Two Intraocular Gas Injection Techniques in Macula Hole Surgery

Conditions
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Macular Holes

Intervention / Treatment
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* Drug: small amount of undiluted C3F8


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: small amount of undiluted C3F8<br> | Drug: small amount of undiluted C3F8<br>* vitrectomy followed by peeling of the internal limiting membrane and, after that, intraocular gas injection<br>|
| Active Comparator: large amount of diluted C3f8<br> | Drug: small amount of undiluted C3F8<br>* vitrectomy followed by peeling of the internal limiting membrane and, after that, intraocular gas injection<br>|
| Active Comparator: small amount of undiluted SF6<br> | Drug: small amount of undiluted C3F8<br>* vitrectomy followed by peeling of the internal limiting membrane and, after that, intraocular gas injection<br>|
| Active Comparator: large amount of diluted SF6<br> | Drug: small amount of undiluted C3F8<br>* vitrectomy followed by peeling of the internal limiting membrane and, after that, intraocular gas injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gas duration | duration of intraocular gas | up to 60 days | 
| macula hole closure | closure of the macular hole after the primary surgical procedure | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity | corrected distance visual acuity | preoperative, 26 weeks | 
| intraocular pressure | intraocular pressure | preoperative, 1 day, 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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macular holes, Injections, Intra-Ocular, gases