Comparison Between Deep Sclerectomy and Traditional Trabeculotomy & Trabeculectomy in Congenital Glaucoma

NCT01460017 | Unknown Phase 1

• 1 other identifier: E-11-487
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that deep sclerectomy in congenital glaucoma is a safer procedure and may yield better results than trabeculotomy trabeculectomy approach.

Conditions

Congenital Glaucoma

Outcome Measures

Primary Outcomes (1)

• reduction in IOP

  decrease in the intraocular pressure to the normal limit (\<22 - \>6) mmHg

  6 month

Study Arms (2)

DS arm

ACTIVE COMPARATOR

Deep sclerectomy surgery will be conduct in this arm

Procedure: Deep Sclerectomy

Trab arm

ACTIVE COMPARATOR

combined Trabeculectomy and Trabeculotomy surgery will be conducted in this arm

Procedure: Combined Trab

Interventions

Deep Sclerectomy PROCEDURE

Non penetrating glaucoma surgery is a new procedure in adults that has less post operative complications with good results, it is to be applied in children.

Also known as: Non penetrating DS

DS arm

Combined Trab PROCEDURE

Combined trabeculectomy and trabeculotomy is a standard surgery for congenital glaucoma, however, it has its known complications.

Also known as: Combined Trabeculectomy Trabeculotomy

Trab arm

Eligibility Criteria

• Age: 1 Day - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Any case diagnosed as congenital glaucoma with enlarged corneal diameter more than 11 mm and intra-ocular pressure above 21 mmHg, including corneal edema or Habb's Stria with or without optic disc cupping.
• Any case diagnosed as primary or secondary congenital glaucoma to ocular or systemic abnormalities.
• Within the age of (0 - 12).

You may not qualify if:

• Cases of congenital glaucoma with previous intervention.
• Age above 12 Yrs.
• Cases with secondary glaucoma caused by surgical intervention, ocular co-morbidity, medications or trauma

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

King Abdul Aziz University Hospital

Riyadh, Riyadh Region, 11411, Saudi Arabia

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 Officials

• Saleh A. Al-Obeidan, MD

  King Saud University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: October 25, 2011
• First Posted: October 26, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 26, 2011

Record last verified: 2011-10

Locations

SA (1)