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

Comparison Between The Outcome of Deep Sclerectomy and Traditional Trabeculotomy and Trabeculectomy Surgeries in Congenital Glaucoma

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01460017
Enrollment
40
Registered
2011-10-26
Start date
2011-11-30
Completion date
2013-12-31
Last updated
2011-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Glaucoma

Brief summary

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

Detailed description

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.

Interventions

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.

PROCEDURECombined Trab

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

Sponsors

King Saud University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
1 Days to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
reduction in IOP6 monthdecrease in the intraocular pressure to the normal limit (\<22 - \>6) mmHg

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026