Optical Coherence Tomography of the Irido-Corneal Angle Before and After Goniotomy and Trabeculotomy in Primary Congenital Glaucoma

NCT07012252 | Completed

• 1 other identifier: D-36-2019
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The research aimed to improve surgical techniques and long-term outcomes by utilizing this advanced imaging technology to illuminate the structural abnormalities of the anterior segment in eyes with primary congenital glaucoma.

Conditions

Optical Coherence Tomography; Anterior Chamber Angle; Goniotomy; Trabeculotomy; Primary Congenital Glaucoma

Outcome Measures

Primary Outcomes (1)

• Central corneal thickness

  Central corneal thickness was measured using handheld anterior segment optical coherence tomography (HH AS-OCT).

  6 months post-procedure

Secondary Outcomes (2)

• Trabecular-iris angle

  6 months post-procedure

• Iris thickness

  6 months post-procedure

Study Arms (1)

Primary congenital glaucoma group

EXPERIMENTAL

Infants with primary congenital glaucoma.

Procedure: Optical coherence tomography

Interventions

Optical coherence tomography PROCEDURE

Infants underwent optical coherence tomography.

Primary congenital glaucoma group

Eligibility Criteria

• Age: 1 Week - 72 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age from 1 to 72 weeks.
• Both sexes.
• Infants with primary congenital glaucoma.

You may not qualify if:

• Eyes in which the angle could not be visualized by the handheld anterior segment optical coherence tomography (HH AS-OCT).
• Eyes with previous intraocular surgery.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

Location

MeSH Terms

Conditions

Hydrophthalmos

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Eye Abnormalities; Eye Diseases; Glaucoma, Open-Angle; Glaucoma; Ocular Hypertension; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Specialist of Ophthalmology at Ministry of Health of Egypt.

Study Record Dates

• First Submitted: May 31, 2025
• First Posted: June 10, 2025
• Study Start: October 1, 2018
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: June 10, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)