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Comparison of Two Intraocular Gas Injection Techniques in Macula Hole Surgery

Primary Purpose

Macular Holes

Status

Completed

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

small amount of undiluted C3F8

About this trial

This is an interventional treatment trial for Macular Holes focused on measuring macular holes, Injections, Intra-Ocular, gases

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

UFPE Ophthalmology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

small amount of undiluted C3F8

large amount of diluted C3f8

small amount of undiluted SF6

large amount of diluted SF6

Arm Description

Outcomes

Primary Outcome Measures

Gas duration

duration of intraocular gas

macula hole closure

closure of the macular hole after the primary surgical procedure

Secondary Outcome Measures

visual acuity

corrected distance visual acuity

intraocular pressure

Full Information

NCT ID

NCT04527848

First Posted

August 23, 2020

Last Updated

December 7, 2020

Sponsor

Universidade Federal de Pernambuco

1. Study Identification

Unique Protocol Identification Number

NCT04527848

Brief Title

Comparison of Two Intraocular Gas Injection Techniques in Macula Hole Surgery

Official Title

Comparison of Two Intraocular Gas Injection Techniques in Macula Hole Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

May 10, 2016 (Actual)

Primary Completion Date

July 31, 2020 (Actual)

Study Completion Date

July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidade Federal de Pernambuco

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Macular Holes

Keywords

macular holes, Injections, Intra-Ocular, gases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes 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).

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

small amount of undiluted C3F8

Arm Type

Experimental

Arm Title

large amount of diluted C3f8

Arm Type

Active Comparator

Arm Title

small amount of undiluted SF6

Arm Type

Active Comparator

Arm Title

large amount of diluted SF6

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

small amount of undiluted C3F8

Intervention Description

vitrectomy followed by peeling of the internal limiting membrane and, after that, intraocular gas injection

Primary Outcome Measure Information:

Title

Gas duration

Description

duration of intraocular gas

Time Frame

up to 60 days

Title

macula hole closure

Description

closure of the macular hole after the primary surgical procedure

Time Frame

26 weeks

Secondary Outcome Measure Information:

Title

visual acuity

Description

corrected distance visual acuity

Time Frame

preoperative, 26 weeks

Title

intraocular pressure

Description

intraocular pressure

Time Frame

preoperative, 1 day, 26 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rodrigo PC Lira, PhD

Organizational Affiliation

UFPE

Official's Role

Principal Investigator

Facility Information:

Facility Name

UFPE Ophthalmology

City

Recife

State/Province

ZIP/Postal Code

50740600

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

Comparison of Two Intraocular Gas Injection Techniques in Macula Hole Surgery

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