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OpenTrials
Completed

NCT Number: NCT04683289

Visco-Circumferential-Suture-Trabeculotomy Versus Trabeculotomy

comparing outcomes of Visco-Circumferential-Suture-Trabeculotomy in primary congenital glaucoma to trabeculotomy

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Key information

Conditions

Primary Congenital Glaucoma Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Abnormalities Eye Diseases Glaucoma Glaucoma, Open-Angle Hydrophthalmos Infant, Newborn, Diseases Ocular Hypertension

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ophthalmic Center

Al Mansurah, 35516, Egypt

About this study

prospective randomized interventional study conducted on infants below the age of 2 years with PCG attending the outpatient clinic of Mansoura Ophthalmic Center of Mansoura University were recruited to compare the long-term surgical outcomes of this proposed technique (VCST) and rigid probe VT in patients with PCG.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • infants below the age of 2 years with PCG

Exclusion criteria

  • patients older than 2 years on presentation
  • eyes with previous surgery
  • eyes with secondary glaucoma
  • eyes diagnosed as anterior segment dysgenesis syndrome

Treatment and study plan

Trabeculotomy

Procedure

performing partial unroofing of the SC and viscoelastic injection into the 2 ostia of the canal. This was followed by connecting the scalemm canal to the anterior chamber

Primary outcomes

  1. IOP

    Time frame: 36 months

    intraocular pressure measuring

Secondary outcomes

  1. complications

    Time frame: 36 months months

    visual devastating complications

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Surgical Outcomes of Visco-Circumferential-Suture-Trabeculotomy in Primary Congenital Glaucoma: A 3-year Randomized Controlled Study

Important dates

Study start
2015
Primary completion
2017
Study completion
2020
First posted
Dec 24, 2020
Registry last updated
Dec 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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