Compare the Healing Process of Idiopathic Macular Hole Wi... | NCT03888625

Studies
Compare the Healing Process of Idiopathic Macular Hole With Different Surgical Techniques

NCT03888625

Sponsor

Federal University of São Paulo

Status

Unknown status

Last Update Posted

Mar 25, 2019Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Macular Holes

Interventions

Conventional ILM Peeling
Inverted ILM Peeling

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

Mar 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2018Actual

Primary Completion Date

Jun 15, 2020Estimated

Completion Date

Jun 30, 2020Estimated

First Submitted Date

Mar 21, 2019

First Submission Date that Met QC Criteria

Mar 22, 2019

First Posted Date

Mar 25, 2019Actual

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

Mar 22, 2019

Last Update Posted Date

Mar 25, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mauricio Maia, Professor of Ophthalmology Dept, Federal University of São PauloPrincipal Investigator

Lead Sponsor

Federal University of São PauloOTHER

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 compare anatomic and functional results, and to evaluate postoperatively the healing process in 2 different techniques for the closure of the macular holes (MH)

Detailed Description

Patients with macular holes classified in stages 3 and 4 will be randomized into 2 groups. . In Group A, patients will undergo peeling with complete removal of the internal limiting membrane (ILM) and in the group B, the inverted ILM peeling technique will be performed. The 20% sulfur hexafluoride (SF6) gas will be used as a tamponade agent in all surgeries, and patients will be instructed to avoid the prone position for 5 days.

OCT images will be performed in the first 5 postoperative days and months 1, 3 and 6.

The primary outcome is anatomic closure of the MH closure in the month 6. The second outcomes are: mean best corrected visual acuity (BCVA) at month 6, mean change in the BCVA at month 6; integrity of the perifoveal external limiting membrane and ellipsoid zone on Optical Coherence Tomography (OCT); MH closure rate over time in days; functional improvement of microperimetry Statistical analysis will be performed with Student t-test and the p-value of ≤ 0.05 is considered significant.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A: Conventional ILM peeling	Active Comparator	peeling with complete removal of the internal limiting membrane (ILM)	Procedure: Conventional ILM Peeling
GroupB: Inverted ILM Peeling	Active Comparator	the inverted ILM peeling technique, in which the ILM is left in the edge of the macular hole and the free area is inverted over the macular hole before fluid-air exchange	Procedure: Inverted ILM Peeling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Conventional ILM Peeling	Procedure	peeling with complete removal of the internal limiting membrane (ILM)	Group A: Conventional ILM peeling

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of Anatomic closure	Rate of anatomic macular hole closure in the OCT at month 6	Month 6 post operative

Secondary Outcomes

Measure	Description	Time Frame
BCVA mean	mean best corrected visual acuity (BCVA) at month 6	Month 6 post operative
BCVA change	change in the BCVA at month 6	Screening and Month 6 post operative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

> Stage 3 and 4 macular holes with visual acuity between 20/30 and 20/800 according to the ETDRS chart.

Exclusion Criteria:

Macular holes secondary to ocular trauma, myopia or retinal detachment
Any previous treatment for the macular hole
Evidence on examination of any diabetic retinopathy
History or presence of wet or dry age macular degeneration (AMD)
Presence of epiretinal membrane or prior uveitis
Any ocular surgery within 3 months before baseline
Intra or periocular infection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mauricio Maia, MD, PhD	Contact	+55-18-991137727		maiamauricio@terra.com.br
Luci p Silva, PhD, MBA	Contact	11971571967		luci.pesquisa@gmail.com

Overall Officials

Name	Affiliation	Role
Mauricio Maia, MD, PhD	Federal University of São Paulo	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Ophthalmology	Recruiting	São Paulo		04023-062	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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

Intervention Model Description

In Group A, patients will undergo peeling with complete removal of the internal limiting membrane (ILM) and in the group B, the inverted ILM peeling technique will be performed.