Extensive Circumferential Partial Thickness Sclerectomy in Nanophthalmic Eyes

November 18, 2018 updated by: Ahmad Mansour, MD, Clinical Professor, AUB, Rafic Hariri University Hospital

Purpose: To describe an extensive scleral excision technique to treat or prevent uveal effusion in nanophthalmic eyes.

Design: Prospective interventional case series.

Methods:

  • Setting: Institutional.
  • Patient Population: Consecutive patients with nanophthalmos were operated on by one surgeon.
  • Intervention Procedure: A single, 90% thickness scleral window extending from immediately behind the extraocular muscle insertions to the vortex veins was performed for 3 and 1/4 quadrants as a circumferential strip.
  • Main Outcome Measure: Resolution or prevention of uveal effusion.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Surgical Technique All surgeries were performed under general anesthesia by one surgeon (AMM). Because the majority of the patients were young with narrow palpebral fissures and very deep set globes in small orbits, special surgical techniques were required. Lateral canthotomy was performed on all patients except for the first. Limbal 360o conjunctival peritomy was followed by securing of each rectus muscles with a modified muscle hook and 2-0 silk suture. Scleral dissection was performed from immediately behind to the muscle insertions posterior to the vortex veins. A 90% depth scleral window was excised over 3 and ¼ quadrants, excluding 3/4 of the superior temporal quadrant to avoid damaging the superior oblique muscle.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lebanon
    • South Beirut
      • Beirut, South Beirut, Lebanon, 1136044
        • Rafic Hariri University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: nanophthalmos -

Exclusion Criteria: None

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
resolution of uveal effusion
Time Frame: 1 month
disappearence of uveal effusion by OCT
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rafic Hariri University Hospital

Investigators

  • Study Chair: Ahmad Mansour, MD, Rafic Hariri University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2011

Primary Completion (ANTICIPATED)

January 1, 2020

Study Completion (ANTICIPATED)

January 1, 2020

Study Registration Dates

First Submitted

November 18, 2018

First Submitted That Met QC Criteria

November 18, 2018

First Posted (ACTUAL)

November 21, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 21, 2018

Last Update Submitted That Met QC Criteria

November 18, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RaficHaririUHAMM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

if part of collaboration, we will share the data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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