MedTrace Logo

COSOPT-S® Treatment Versus Acetazolamide Before Trabeculectomy

NCT01228149 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2017-08-01

Study results available
· View outcomes & findings →

Summary

The most common cause of post-trabeculectomy filtration failure is postoperative scarring. Long-term preoperative treatment with local antiglaucoma agents containing preservatives has an increased risk of post-operative scarring of the filtration bleb. Therefore many surgeons prepare their patients for planned trabeculectomy by discontinuing local antiglaucoma drugs, controlling IOP with oral acetazolamide, and treating the eye with local steroids.

Preservative-free COSOPT-S® eye drops b.i.d now provide a possibility to reduce IOP preoperatively with the aim of avoiding postoperative excessive scarring and the known adverse effects of oral acetazolamide while achieving comparable IOP reduction and long-term outcomes.

This study will investigate comparability (non-inferiority) of medical benefits of two different IOP lowering pharmaceutical interventions prior to trabeculectomy comparing COSOPT-S® bid to oral acetazolamide plus dexamethasone.

Conditions

Interventions

DRUG

Trabeculectomy with preoperative Diamox/DexaEDO treatment

Filtrating glaucoma surgery, preoperative treatment with Diamox (acetazolamide) 28 day prior surgery. DexaEDO (dexamethasone) 7 days prior surgery

DRUG

Trabeculectomy with preoperative Cosopt S treatment

Filtrating glaucoma surgery, preoperative treatment with Cosopt S (dorzolamide/timolol) 28 day prior surgery.

Sponsors & Collaborators

  • Katrin Lorenz

    lead OTHER

Principal Investigators

  • Katrin Lorenz, MD · Johannes Gutenberg University Mainz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01228149 on ClinicalTrials.gov