Comparison of Two Intraocular Gas Injection Techniques in Macula Hole Surgery

December 7, 2020 updated by: Rodrigo Pessoa Cavalcanti Lira, Universidade Federal de Pernambuco
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • PE
      • Recife, PE, Brazil, 50740600
        • UFPE Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Pernambuco

Investigators

  • Principal Investigator: Rodrigo PC Lira, PhD, UFPE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2016

Primary Completion (Actual)

July 31, 2020

Study Completion (Actual)

July 31, 2020

Study Registration Dates

First Submitted

August 23, 2020

First Submitted That Met QC Criteria

August 23, 2020

First Posted (Actual)

August 27, 2020

Study Record Updates

Last Update Posted (Actual)

December 9, 2020

Last Update Submitted That Met QC Criteria

December 7, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12347319.9.0000.8807

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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