Comparison of Two Intraocular Gas Injection Techniques in Macula Hole Surgery
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2016
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2020
CompletedFirst Submitted
Initial submission to the registry
August 23, 2020
CompletedFirst Posted
Study publicly available on registry
August 27, 2020
CompletedDecember 9, 2020
December 1, 2020
4.2 years
August 23, 2020
December 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
visual acuity
preoperative, 26 weeks
intraocular pressure
preoperative, 1 day, 26 weeks
Study Arms (4)
small amount of undiluted C3F8
EXPERIMENTALlarge amount of diluted C3f8
ACTIVE COMPARATORsmall amount of undiluted SF6
ACTIVE COMPARATORlarge amount of diluted SF6
ACTIVE COMPARATORInterventions
vitrectomy followed by peeling of the internal limiting membrane and, after that, intraocular gas injection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UFPE Ophthalmology
Recife, Pernambuco, 50740600, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rodrigo PC Lira, PhD
UFPE
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- The individuals were randomized in a 1: 1: 1: 1 ratio. Block sizes of 4 individuals stratified according to gas type were used (SF6 or C3F8). In each block, two individuals were allocated to each group (0.9-1.0 mL of 100% gas or 15-20 mL of 20% gas).
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 23, 2020
First Posted
August 27, 2020
Study Start
May 10, 2016
Primary Completion
July 31, 2020
Study Completion
July 31, 2020
Last Updated
December 9, 2020
Record last verified: 2020-12