Comparison of Two Intraocular Gas Injection Techniques in Macula Hole Surgery
NCT ID: NCT04527848
Last Updated: 2020-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
48 participants
INTERVENTIONAL
2016-05-10
2020-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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small amount of undiluted C3F8
small amount of undiluted C3F8
vitrectomy followed by peeling of the internal limiting membrane and, after that, intraocular gas injection
large amount of diluted C3f8
small amount of undiluted C3F8
vitrectomy followed by peeling of the internal limiting membrane and, after that, intraocular gas injection
small amount of undiluted SF6
small amount of undiluted C3F8
vitrectomy followed by peeling of the internal limiting membrane and, after that, intraocular gas injection
large amount of diluted SF6
small amount of undiluted C3F8
vitrectomy followed by peeling of the internal limiting membrane and, after that, intraocular gas injection
Interventions
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small amount of undiluted C3F8
vitrectomy followed by peeling of the internal limiting membrane and, after that, intraocular gas injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
ALL
No
Sponsors
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Universidade Federal de Pernambuco
OTHER
Responsible Party
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Rodrigo Pessoa Cavalcanti Lira
Professor
Principal Investigators
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Rodrigo PC Lira, PhD
Role: PRINCIPAL_INVESTIGATOR
UFPE
Locations
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UFPE Ophthalmology
Recife, Pernambuco, Brazil
Countries
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Other Identifiers
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12347319.9.0000.8807
Identifier Type: -
Identifier Source: org_study_id