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Comparison of Two Intraocular Gas Injection Techniques in Macula Hole Surgery

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ClinicalTrials.gov Identifier: NCT04527848
Recruitment Status : Completed
First Posted : August 27, 2020
Last Update Posted : December 9, 2020
Sponsor:
Information provided by (Responsible Party):
Rodrigo Pessoa Cavalcanti Lira, Universidade Federal de Pernambuco

Study Description
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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.

Condition or disease Intervention/treatment Phase
Macular Holes Drug: small amount of undiluted C3F8 Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: 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).
Primary Purpose: Treatment
Official Title: Comparison of Two Intraocular Gas Injection Techniques in Macula Hole Surgery
Actual Study Start Date : May 10, 2016
Actual Primary Completion Date : July 31, 2020
Actual Study Completion Date : July 31, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: small amount of undiluted C3F8 Drug: small amount of undiluted C3F8
vitrectomy followed by peeling of the internal limiting membrane and, after that, intraocular gas injection
Active Comparator: large amount of diluted C3f8 Drug: small amount of undiluted C3F8
vitrectomy followed by peeling of the internal limiting membrane and, after that, intraocular gas injection
Active Comparator: small amount of undiluted SF6 Drug: small amount of undiluted C3F8
vitrectomy followed by peeling of the internal limiting membrane and, after that, intraocular gas injection
Active Comparator: large amount of diluted SF6 Drug: small amount of undiluted C3F8
vitrectomy followed by peeling of the internal limiting membrane and, after that, intraocular gas injection


Outcome Measures
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Primary Outcome Measures :
  1. Gas duration [ Time Frame: up to 60 days ]
    duration of intraocular gas

  2. macula hole closure [ Time Frame: 26 weeks ]
    closure of the macular hole after the primary surgical procedure


Secondary Outcome Measures :
  1. visual acuity [ Time Frame: preoperative, 26 weeks ]
    corrected distance visual acuity

  2. intraocular pressure [ Time Frame: preoperative, 1 day, 26 weeks ]
    intraocular pressure


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04527848


Locations
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Brazil
UFPE Ophthalmology
Recife, PE, Brazil, 50740600
Sponsors and Collaborators
Universidade Federal de Pernambuco
Investigators
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Principal Investigator: Rodrigo PC Lira, PhD UFPE
More Information
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Responsible Party: Rodrigo Pessoa Cavalcanti Lira, Professor, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT04527848    
Other Study ID Numbers: 12347319.9.0000.8807
First Posted: August 27, 2020    Key Record Dates
Last Update Posted: December 9, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rodrigo Pessoa Cavalcanti Lira, Universidade Federal de Pernambuco:
macular holes
Injections, Intra-Ocular
gases
Additional relevant MeSH terms:
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Retinal Perforations
Retinal Diseases
Eye Diseases