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OpenTrials
Completed

NCT Number: NCT03185936

Surgical Management of Optic Disc Pit Maculaopathy

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.

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Key information

Age range

15 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Other names: Endolaser photocoagulation

Primary outcomes

  1. anatomical improvement

    Time frame: 6 months

    Retinal reattachment

Secondary outcomes

  1. Functional improvement

    Time frame: 6 months

    Visual acuity letters gain

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Pars Plana Vitrectomy With Internal Limiting Membrane Peeling in Optic Disc Pit Maculopathy

Important dates

Study start
2011
Primary completion
2016
Study completion
2017
First posted
Jun 14, 2017
Registry last updated
Jun 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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