MicrocatheterTrabeculotomy in Primary Congenital Glaucoma

NCT04116450 | Completed DMC

• 1 other identifier: Minia U, Glaucoma unit
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

PURPOSE: To study circumferential trabeculotomy for congenital glaucoma using Glaucolight illuminated microcatheter. Setting: Ophthalmology department, Faculty of Medicine, Minia University, 61519, El-Minia, Egypt. DESIGN: Prospective, randomized, consecutive interventional study METHODS: This was a prorospective study of 25 eyes of 25 patients with primary congenital or juvenile glaucoma those underwent circumferential trabeculotomy done with an illuminated microcatheter through a period of 24 months. Patients data of 12 months follow-up were recorded. The primary target was mean intraocular pressure (IOP) study in which unqualified (complete success) was defined as an IOP ≤21 mm Hg and at least a 30% reduction without the use of antiglaucoma drugs and a qualified success when medications were used to reach this aim. The secondary target was studding the corneal diameter (CD) and cup disc ratio (C/D) change.

Conditions

Primary Congenital Glaucoma

Outcome Measures

Primary Outcomes (1)

• Intra-ocular pressure

  The primary target was mean intraocular pressure (IOP) study in which unqualified (complete success) was defined as an IOP ≤21 mm Hg and at least a 30% reduction without the use of antiglaucoma drugs and a qualified success when medications were used to reach this aim.

  one year

Secondary Outcomes (2)

• corneal diameer

  1 year

• cup discratio

  1 year

Study Arms (1)

primary congenital glaucoma

OTHER

Glaucolight illuminated microcatheter trabeculotomy in primary congenital glaucoma

Procedure: Glaucolight illuminated microcatheter.

Interventions

Glaucolight illuminated microcatheter. PROCEDURE

To study circumferential trabeculotomy for congenital glaucoma using Glaucolight illuminated microcatheter.

Also known as: circumferential trabeculotomy for congenital glaucoma using Glaucolight illuminated microcatheter.

primary congenital glaucoma

Eligibility Criteria

• Age: 2 Months - 48 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The study included children aged below 6 years with PCG with or without antiglaucoma medications and not had previous antiglaucoma surgery with successful 360°trabeculotomy.

You may not qualify if:

• Eyes that needs combined operation, previous antiglaucoma procedure and incomplete trabeculotomy ≤360°.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia University

Minya, 61519, Egypt

Location

Related Publications (2)

• El Sayed Y, Gawdat G. Two-year results of microcatheter-assisted trabeculotomy in paediatric glaucoma: a randomized controlled study. Acta Ophthalmol. 2017 Dec;95(8):e713-e719. doi: 10.1111/aos.13414. Epub 2017 Mar 7.

  PMID: 28266150 BACKGROUND

• Morales J, Al Shahwan S, Al Odhayb S, Al Jadaan I, Edward DP. Current surgical options for the management of pediatric glaucoma. J Ophthalmol. 2013;2013:763735. doi: 10.1155/2013/763735. Epub 2013 Apr 24.

  PMID: 23738051 BACKGROUND

MeSH Terms

Conditions

Hydrophthalmos

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

Study Officials

• mahmoud M Genaidy, MD

  Minia University

  STUDY DIRECTOR

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 professor of ophthalmology

Model Details: 25 patient underwent Glaucolight illuminated microcatheter for primary congenital glaucoma

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 4, 2019
• Study Start: June 1, 2017
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: October 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)