Comparison of Two Intraocular Gas Injection Techniques in... | NCT04527848

Studies
Comparison of Two Intraocular Gas Injection Techniques in Macula Hole Surgery

NCT04527848

Sponsor

Universidade Federal de Pernambuco

Status

Completed

Last Update Posted

Dec 9, 2020Actual

Enrollment

48Actual

Phase

Phase 4

Conditions

Macular Holes

Interventions

small amount of undiluted C3F8

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 10, 2016Actual

Primary Completion Date

Jul 31, 2020Actual

Completion Date

Jul 31, 2020Actual

First Submitted Date

Aug 23, 2020

First Submission Date that Met QC Criteria

Aug 23, 2020

First Posted Date

Aug 27, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2020

Last Update Posted Date

Dec 9, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rodrigo Pessoa Cavalcanti Lira, Professor, Universidade Federal de PernambucoPrincipal Investigator

Lead Sponsor

Universidade Federal de PernambucoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
small amount of undiluted C3F8	Experimental	Drug: small amount of undiluted C3F8
large amount of diluted C3f8	Active Comparator	Drug: small amount of undiluted C3F8
small amount of undiluted SF6	Active Comparator	Drug: small amount of undiluted C3F8
large amount of diluted SF6	Active Comparator	Drug: small amount of undiluted C3F8

Interventions

Name	Type	Description	Arm Group Labels	Other Names
small amount of undiluted C3F8	Drug	vitrectomy followed by peeling of the internal limiting membrane and, after that, intraocular gas injection	large amount of diluted C3f8

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rodrigo PC Lira, PhD	UFPE	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UFPE Ophthalmology		Recife	Pernambuco	50740600	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D012167	Retinal Perforations

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Double

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).

Who Masked

ParticipantOutcomes Assessor