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OpenTrials
Completed

NCT Number: NCT07012252

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

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.

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Key information

Conditions

Optical Coherence Tomography Anterior Chamber Angle Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Abnormalities Eye Diseases Glaucoma Glaucoma, Open-Angle Goniotomy Hydrophthalmos Infant, Newborn, Diseases Ocular Hypertension Primary Congenital Glaucoma Trabeculotomy

Age range

1 week–72 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, 12613, Egypt

About this study

Primary congenital glaucoma (PCG) is a rare disease, but it is responsible for 2.5%-15% of all documented cases of pediatric blindness.

The main target of the treatment of pediatric glaucoma is to control the IOP surgically. However, medical treatment could be instituted as a temporary and/or adjunctive option to maximize Intraocular pressure (IOP) control. Initial goniotomy or trabeculotomy have been detected to have high success rates. Trabeculotomy has a comparable long-term success rate in most patients of PCG. The success rate of trabeculotomy is lower in advanced or late-presenting patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Optical Coherence Tomography

Procedure

Infants underwent optical coherence tomography.

Primary outcomes

  1. Central corneal thickness

    Time frame: 6 months post-procedure

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

Secondary outcomes

  1. Trabecular-iris angle

    Time frame: 6 months post-procedure

    Trabecular-iris angle was measured using handheld anterior segment optical coherence tomography (HH AS-OCT).

  2. Iris thickness

    Time frame: 6 months post-procedure

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 10, 2025
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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