NCT03748732

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
7.9 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 21, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

November 21, 2018

Status Verified

November 1, 2018

Enrollment Period

9 years

First QC Date

November 18, 2018

Last Update Submit

November 18, 2018

Conditions

Nanophthalmos

Keywords

uveal effusion

Outcome Measures

Primary Outcomes (1)

  • resolution of uveal effusion

    disappearence of uveal effusion by OCT

    1 month

Interventions

sclerectomyPROCEDURE

scleral flap

Also known as: maximal scleral excision

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rafic Hariri University Hospital

Beirut, South Beirut, 1136044, Lebanon

Location

Related Publications (2)

  • 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.

    PMID: 29862063RESULT

  • 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.

    PMID: 30877130DERIVED

MeSH Terms

Conditions

Microphthalmos

Condition Hierarchy (Ancestors)

Eye AbnormalitiesEye DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Ahmad Mansour, MD

    Rafic Hariri University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: surgery
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 18, 2018

First Posted

November 21, 2018

Study Start

January 1, 2011

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

November 21, 2018

Record last verified: 2018-11

Locations

LE(1)