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

NCT ID: NCT01460017

Last Updated: 2011-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-12-31

Brief Summary

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

Detailed Description

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Non penetrating glaucoma surgery depends on filtration through trabeculo-descmeto window as well as supra-choroidal space less to sub-conjunctival rout. the nature of the operation keeps the globe intact without penetration that leads to less complications compared to penetrating trabeculectomy combined with trabeculotomy.

Conditions

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Congenital Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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DS arm

Deep sclerectomy surgery will be conduct in this arm

Group Type ACTIVE_COMPARATOR

Deep Sclerectomy

Intervention Type 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.

Trab arm

combined Trabeculectomy and Trabeculotomy surgery will be conducted in this arm

Group Type ACTIVE_COMPARATOR

Combined Trab

Intervention Type PROCEDURE

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

Interventions

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Deep Sclerectomy

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.

Intervention Type PROCEDURE

Combined Trab

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

Intervention Type PROCEDURE

Other Intervention Names

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Non penetrating DS Combined Trabeculectomy Trabeculotomy

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* 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
Minimum Eligible Age

1 Day

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Saud University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Ahmed Mousa

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Saleh A. Al-Obeidan, MD

Role: PRINCIPAL_INVESTIGATOR

King Saud University

Locations

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King Abdul Aziz University Hospital

Riyadh, Riyadh Region, Saudi Arabia

Site Status

Countries

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Saudi Arabia

Facility Contacts

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Saleh A. Al-Obeidan, MD

Role: primary

[email protected]
+96614786100 ext. 1425

Essam A. Osman, FRCS

Role: backup

[email protected]
+966507449080

Other Identifiers

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E-11-487

Identifier Type: -

Identifier Source: org_study_id