Extensive Circumferential Partial Thickness Sclerectomy in Nanophthalmic Eyes

Sponsor

Rafic Hariri University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03748732

Collaborator

(none)

Enrollment

Location

108

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Nanophthalmos	Procedure: sclerectomy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

surgerysurgery

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Extensive Circumferential Partial Thickness Sclerectomy in Nanophthalmic Eyes

Actual Study Start Date :

Jan 1, 2011

Anticipated Primary Completion Date :

Jan 1, 2020

Anticipated Study Completion Date :

Jan 1, 2020

Outcome Measures

Primary Outcome Measures

resolution of uveal effusion [1 month]
disappearence of uveal effusion by OCT

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria: nanophthalmos -

Exclusion Criteria: None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rafic Hariri University Hospital	Beirut	South Beirut	Lebanon	1136044

Sponsors and Collaborators

Rafic Hariri University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmad Mansour, MD, Clinical Professor, AUB, Professor, Rafic Hariri University Hospital

ClinicalTrials.gov Identifier:

NCT03748732

Other Study ID Numbers:

RaficHaririUHAMM

First Posted:

Nov 21, 2018

Last Update Posted:

Nov 21, 2018

Last Verified:

Nov 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ahmad Mansour, MD, Clinical Professor, AUB, Professor, Rafic Hariri University Hospital

uveal effusion

Additional relevant MeSH terms:

Microphthalmos

Study Results

No Results Posted as of Nov 21, 2018