Extensive Circumferential Partial Thickness Sclerectomy in Nanophthalmic Eyes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT03748732

Recruitment Status : Unknown

Verified November 2018 by Ahmad Mansour, MD, Clinical Professor, AUB, Rafic Hariri University Hospital.
Recruitment status was: Active, not recruiting

First Posted : November 21, 2018

Last Update Posted : November 21, 2018

Sponsor:

Information provided by (Responsible Party):

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

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	Not Applicable

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

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	30 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Intervention Model Description:	surgery
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Extensive Circumferential Partial Thickness Sclerectomy in Nanophthalmic Eyes
Actual Study Start Date :	January 1, 2011
Estimated Primary Completion Date :	January 1, 2020
Estimated Study Completion Date :	January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Microphthalmia with linear skin defects syndrome Microphthalmia

Genetic and Rare Diseases Information Center resources: Microphthalmia

U.S. FDA Resources

Arms and Interventions

Intervention Details:

Procedure: sclerectomy
scleral flap

Other Name: maximal scleral excision

Outcome Measures

Primary Outcome Measures :

resolution of uveal effusion [ Time Frame: 1 month ]
disappearence of uveal effusion by OCT

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria: nanophthalmos -

Exclusion Criteria: None

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748732

Locations

Layout table for location information

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

Sponsors and Collaborators

Rafic Hariri University Hospital

Investigators

Layout table for investigator information

Study Chair:	Ahmad Mansour, MD	Rafic Hariri University Hospital

More Information

Publications of Results:

Carricondo PC, Andrade T, Prasov L, Ayres BM, Moroi SE. Nanophthalmos: A Review of the Clinical Spectrum and Genetics. J Ophthalmol. 2018 May 9;2018:2735465. doi: 10.1155/2018/2735465. eCollection 2018. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mansour A, Stewart MW, Shields CL, Hamam R, Abdul Fattah M, Sheheitli H, Mehanna CJ, Yassine S, Chahine H, Keaik M, Maalouf F, Jaroudi M. Extensive circumferential partial-thickness sclerectomy in eyes with extreme nanophthalmos and spontaneous uveal effusion. Br J Ophthalmol. 2019 Dec;103(12):1862-1867. doi: 10.1136/bjophthalmol-2018-313702. Epub 2019 Mar 15.

Layout table for additonal information

Responsible Party:	Ahmad Mansour, MD, Clinical Professor, AUB, Professor, Rafic Hariri University Hospital
ClinicalTrials.gov Identifier:	NCT03748732
Other Study ID Numbers:	RaficHaririUHAMM
First Posted:	November 21, 2018 Key Record Dates
Last Update Posted:	November 21, 2018
Last Verified:	November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided
Plan Description:	if part of collaboration, we will share the data

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

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


uveal effusion

Additional relevant MeSH terms:

Layout table for MeSH terms

Microphthalmos Eye Abnormalities Eye Diseases Congenital Abnormalities

To Top