Surgical Management of Optic Disc Pit Maculaopathy

NCT ID: NCT03185936

Last Updated: 2017-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-01

Study Completion Date

2017-04-01

Brief Summary

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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

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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.

Conditions

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Optic Disc Structural Anomaly Maculopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Optic disc pit maculopathy

pars plana vitrectomy with internal limiting membrane (ILM) peeling, endolaser

Group Type EXPERIMENTAL

pars plana vitrectomy with internal limiting membrane (ILM) peeling

Intervention Type 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.

Interventions

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pars plana vitrectomy with internal limiting membrane (ILM) peeling

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

Intervention Type PROCEDURE

Other Intervention Names

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Endolaser photocoagulation

Eligibility Criteria

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Inclusion Criteria

* Patients included in this study are those with ODP associated with macular detachment
Minimum Eligible Age

15 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Genaidy

Assistant professor of ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mahmud Genaidy, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant professor of ophthalmology, ophthalmology department, Minia university, Egypt

Other Identifiers

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ODP-M

Identifier Type: -

Identifier Source: org_study_id

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