Surgical Management of Optic Disc Pit Maculaopathy

Not Applicable

Completed

• Conditions: Optic Disc Structural Anomaly; Maculopathy
• Interventions: Procedure: pars plana vitrectomy with internal limiting membrane (ILM) peeling

• Registration Number: NCT03185936
• Lead Sponsor: Minia University

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.

Study Timeline

• Study Start: 2011-03-01
• Primary Completion: 2016-04-01
• Study Completion: 2017-04-01
• Status Verified: 2017-06
• Study First Submitted: 2017-06-09
• Study First Submitted QC: 2017-06-09
• Last Update Submitted: 2017-06-09
• Study First Posted: 2017-06-14
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Optic disc pit maculopathy	pars plana vitrectomy with internal limiting membrane (ILM) peeling	pars plana vitrectomy with internal limiting membrane (ILM) peeling, endolaser

Primary Outcome Measures

Name	Time	Method
anatomical improvement	6 months	Retinal reattachment

Secondary Outcome Measures

Name	Time	Method
Functional improvement	6 months	Visual acuity letters gain