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

K

King Saud University

Status and phase

Unknown
Phase 1

Conditions

Congenital Glaucoma

Treatments

Procedure: Deep Sclerectomy
Procedure: Combined Trab

Study type

Interventional

Funder types

Other

Identifiers

NCT01460017
E-11-487

Details and patient eligibility

About

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

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

1 day to 12 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

DS arm
Active Comparator group
Description:
Deep sclerectomy surgery will be conduct in this arm
Treatment:
Procedure: Deep Sclerectomy
Trab arm
Active Comparator group
Description:
combined Trabeculectomy and Trabeculotomy surgery will be conducted in this arm
Treatment:
Procedure: Combined Trab

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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