Efficacy of a new cost effective implant used in treatment of patients with refractory glaucoma.
- Conditions
- Health Condition 1: null- Refractory Glaucoma patients
- Registration Number
- CTRI/2017/07/009089
- Lead Sponsor
- Training Branch
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 38
IOP >=18 mm of Hg with significant optic nerve damage and visual field loss, which had not responded to maximum tolerated conventional antiglaucoma medications/laser or surgical treatment
or
Uncontrolled glaucoma with prior history of Filtering surgery/ Uveitic/ Neovascular/ Secondary glaucoma (Pseudophakia/ Aphakia/ Penetrating keratoplasty/ Vitrectomy/Iridocorneal endothelial syndrome associated glaucoma)/ Developmental glaucoma, considered at high risk of failure/ complication following conventional filtering surgery e.g. significant conjunctival scarring or active neovascular glaucoma
Younger than 18 years
Absent light perception
History of previous cyclodestructive procedure/ aqueous shunt
Uncontrolled glaucoma expected to have favorable post-operative outcome by conventional trabeculectomy Corneal abnormalities that precluded accurate IOP readings
Active ocular disease (e.g. active uveitis, ocular infection)
Uncontrolled systemic diseases.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br/ ><br>Intraocular pressure (IOP) and anti-glaucoma medications requiredTimepoint: Day1, week 1, month 1, month 3, month 6
- Secondary Outcome Measures
Name Time Method Visual acuity, Visual field, Postoperative complications and interventions. Complete success was defined as IOP between 5 mmHg to 18 mmHg without anti-glaucoma medications, without any vision threatening complications or additional glaucoma surgery or laser procedures.Timepoint: Day1, week 1, month 1, month 3, month 6