Status:
COMPLETED
Comparison of Two Intraocular Gas Injection Techniques in Macula Hole Surgery
Lead Sponsor:
Universidade Federal de Pernambuco
Conditions:
Macular Holes
Eligibility:
All Genders
50+ years
Phase:
PHASE4
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 dilut...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 10 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2020
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04527848
Start Date
May 10 2016
End Date
July 31 2020
Last Update
December 9 2020
Active Locations (1)
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1
UFPE Ophthalmology
Recife, Pernambuco, Brazil, 50740600