Surgical Management of Optic Disc Pit Maculaopathy | NCT03185936

Studies
Surgical Management of Optic Disc Pit Maculaopathy

NCT03185936

Sponsor

Minia University

Status

Completed

Last Update Posted

Jun 14, 2017Actual

Enrollment

9Actual

Phase

Not Applicable

Conditions

Optic Disc Structural Anomaly
Maculopathy

Interventions

pars plana vitrectomy with internal limiting membrane (ILM) peeling

Countries

Not provided

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

Jun 2017

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

Mar 1, 2011Actual

Primary Completion Date

Apr 1, 2016Actual

Completion Date

Apr 1, 2017Actual

First Submitted Date

Jun 9, 2017

First Submission Date that Met QC Criteria

Jun 9, 2017

First Posted Date

Jun 14, 2017Actual

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

Jun 9, 2017

Last Update Posted Date

Jun 14, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 evaluate the anatomical and functional results of pars plana vitrectomy (PPV) combined with internal limiting membrane (ILM) peeling, endolaser photocoagulation and gas tamponade in management of optic disc pit (ODP) maculopathy.

Detailed Description

As it is well known, optic disc pit (ODP) is a rare congenital disease which is usually associated with maculopathy (ODP-M) in the form of intraretinal and subretinal fluid accumulation at the macular area leading to visual impairment.

With no definite treatment and absence of guidelines for its management, the invistigators considered their prospective, interventional case series to evaluate the anatomical and functional results of pars plana vitrectomy (PPV) combined with internal limiting membrane (ILM) peeling, endolaser photocoagulation and gas tamponade in management of optic disc pit (ODP) maculopathy.

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

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Optic disc pit maculopathy	Experimental	pars plana vitrectomy with internal limiting membrane (ILM) peeling, endolaser	Procedure: pars plana vitrectomy with internal limiting membrane (ILM) peeling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pars plana vitrectomy with internal limiting membrane (ILM) peeling	Procedure	pars plana vitrectomy (PPV) combined with internal limiting membrane (ILM) peeling, endolaser photocoagulation and gas tamponade in management of optic disc pit (ODP) maculopathy.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
anatomical improvement	Retinal reattachment	6 months

Secondary Outcomes

Measure	Description	Time Frame
Functional improvement	Visual acuity letters gain	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients included in this study are those with ODP associated with macular detachment

Exclusion Criteria:

Exclusion criteria included patients unfit for general anesthesia, those with insufficient clear media to perform the surgery with ILM peeling and those with other ocular diseases that can affect central macular thickness (CMT) and the best corrected visual acuity (BCVA).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mahmud Genaidy, MD	Assistant professor of ophthalmology, ophthalmology department, Minia university, Egypt	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Can not be shared

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008268	Macular Degeneration
D012163	Retinal Detachment

Ancestor Terms

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014080	Tooth Exfoliation

Ancestor Terms

ID	Term
D009063	Dental Physiological Phenomena
D055688	Digestive System and Oral Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided