Subscleral Trabeculectomy With Iris Incarceration in Buphthalmous

NCT04129463 | Completed DMC

• 1 other identifier: Minia University, SST
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: To evaluate a new modification for surgical treatment of Buphthalmous using subscleral trabeculectomy (SST) with iris incarceration Design: Prospective, randomized, consecutive interventional comparative study. Setting: Ophthalmology department, Faculty of Medicine, Minia University, 61519, El-Minia, Egypt. Patients and Methods: This was a prospective study of eyes of 40 eyes with buphthalmous in 25 child 15 bilateral and 10 with unilateral Buphthalmous divided into 2 groups. Group 1 (20 eyes ) those underwent subscleral trabeculectomy (SST) with iris incarceration a new modification to SST and group 2 conventional rigid trabeculotomy through a period of 4 years between Jan., 2015 and Feb., 2019. Patient's data of 2 years follow-up were recorded. The primary outcomes were the mean intraocular pressure (IOP) control in which complete success was defined as an IOP ≤18 mm Hg without the use of anti-glaucoma drugs and a qualified success when medications were used to reach this target and times of another surgical interference till reach IOP control. The secondary outcomes were studding bleb formation, the change in corneal diameter (CD), cup disc ratio (C/D) , and axial length (AXL)

Conditions

Iris Incarceration

Keywords

Buphthalmous; Iris incarceration; SST; IOP; AXL

Outcome Measures

Primary Outcomes (1)

• IOP reduction

  Intra-ocular pressure change in mmHg

  2 years

Secondary Outcomes (3)

• Corneal diameter

  2 years

• Cup/ disc change

  2 years

• AXL change

  2 years

Study Arms (2)

SST with Iris incarceration

ACTIVE COMPARATOR

infants that underwent SST with iris incarceration procedure

Device: Subscleral Trabeculectomy (SST) with Iris incarceration

Conventional trabeculotomy

ACTIVE COMPARATOR

infants that underwent Conventional trabeculotomy

Device: Conventional trabeculotomy

Interventions

Subscleral Trabeculectomy (SST) with Iris incarceration DEVICE

Subscleral Trabeculectomy with Iris Incarceration using iris forceps and scissors

Also known as: Group1

SST with Iris incarceration

Conventional trabeculotomy DEVICE

Conventional trabeculotomy in Buphthalmous using rigid Hans trabeculotome

Also known as: Group 2

Conventional trabeculotomy

Eligibility Criteria

• Age: 2 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The study included infants aged below ≤ 1 year with Buphthalmous with or without antiglaucoma medications and not had previous antiglaucoma surgery.

You may not qualify if:

• Eyes that had previous antiglaucoma procedure or eyes that need combined operation and infants not fit for GA.

Sponsors & Collaborators

• Shaaban Elwan: lead

Study Sites (1)

Minia University

Minya, Egypt

Location

Study Officials

• Shaaban AM Elwan, MD

  Minia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor of ophthalmology

Model Details: Group 1 SST with iris incarceration and group2 conventional trabeculotomy

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 16, 2019
• Study Start: January 1, 2015
• Primary Completion: February 1, 2019
• Study Completion: February 25, 2019
• Last Updated: October 16, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 2 years
• Access Criteria: Data

Locations

EG (1)