Combined Phacoaspiration and Angle Surgery Versus Phacoaspiration in Pediatric Cataract

NCT05401760 | Unknown

• 1 other identifier: R.22.05.1718
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to report the effectiveness of phacoaspiration when combined with angle surgery in preventing postoperative glaucoma following pediatric cataract surgery

Conditions

Pediatric Glaucoma

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure

  glaucoma

  up to one year follow up

Secondary Outcomes (1)

• rate of complications

  one year follow up

Study Arms (2)

Group A: includes eyes for whom combined phacoaspiration & angle surgery will be done.

ACTIVE COMPARATOR

Group A: for whom combined phacoaspiration \& angle surgery trabeculotomy will be done. * continuous curvilinear anterior capsulorhexis of approximately 5.0 mm diameter will be done. * The nucleus and cortex will be aspirated. * Posterior capsulrehxis and limited anterior vitrectomy will be done. * Corneal incisions will be sutured with 10-0 Nylon suture. * Using metal trabeculotomes to open thetrabecular meshwork after accessing the canal of schlemm. * Suturing of scleral flap with 10-0 Nylon suture.

Procedure: Group A :combined phacoaspiration and angle surgery

Group B : includes eyes with only phacoaspiration will be done

ACTIVE COMPARATOR

Group B: for whom phacoaspiration only will be done. * 2 side ports will be fashioned. * Trypan blue will be injected to aid visualization of the anterior capsule \& continuous curvilinear anterior capsulorhexis of approximately 5.0 mm diameter will be done. * The nucleus and cortex will be aspirated. * Posterior capsulrehxis and limited anterior vitrectomy will be done. * Corneal incisions will be sutured with 10-0 Nylon suture.

Procedure: Group B : phacoaspiration only

Interventions

Group A :combined phacoaspiration and angle surgery PROCEDURE

* Partial thickness scleral flap to access the canal of schlemm. * 2 side ports will be fashioned. * Trypan blue will be injected to aid visualization of the anterior capsule \& continuous curvilinear anterior capsulorhexis of approximately 5.0 mm diameter will be done. * The nucleus and cortex will be aspirated. * Posterior capsulrehxis and limited anterior vitrectomy will be done. * Corneal incisions will be sutured with 10-0 Nylon suture. * Using metal trabeculotomes to open thetrabecular meshwork after accessing the canal of schlemm. * Suturing of scleral flap with 10-0 Nylon suture.

Group A: includes eyes for whom combined phacoaspiration & angle surgery will be done.

Group B : phacoaspiration only PROCEDURE

* 2 side ports will be fashioned. * Trypan blue will be injected to aid visualization of the anterior capsule \& continuous curvilinear anterior capsulorhexis of approximately 5.0 mm diameter will be done. * The nucleus and cortex will be aspirated. * Posterior capsulrehxis and limited anterior vitrectomy will be done. * Corneal incisions will be sutured with 10-0 Nylon suture.

Group B : includes eyes with only phacoaspiration will be done

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• pediatric congenital cataract Aged less than two years associated with other ocular anomalies which is high risk for developing glaucoma as microcornea and aniridia.
• pediatric cataract with other eye had post cataract surgery glaucoma

You may not qualify if:

• Acquired cataracts secondary to trauma or uveitis.
• Aged more than two years.
• Associated corneal opacities.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Dina Abd Elfattah

Al Mansurah, Dakahlia Governorate, 35100, Egypt

Location

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of ophthalmology Mansoura University

Model Details: Inclusion criteria: 1. Patients with pediatric congenital cataract Aged less than two years associated with other ocular anomalies which is high risk for developing PCSG as microcornea and aniridia. 2. Patient with pediatric cataract with other eye had post cataract surgery glaucoma

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: June 2, 2022
• Study Start: May 30, 2022
• Primary Completion: November 30, 2022
• Study Completion: March 1, 2023
• Last Updated: September 8, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)