Phacotrabeculotomy vs. CCI+Phaco in Patients With Borderline Control of Intraocular Pressure

Medical University of Vienna0 sites9 target enrollmentDecember 2004

ConditionsPrimary Open Angle Glaucoma Pseudoexfoliative Glaucoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Primary Open Angle Glaucoma
Sponsor: Medical University of Vienna
Enrollment: 9
Primary Endpoint: Number of Patients with Constant Intraocular Pressure <18 mmHg with/without medication
Status: Terminated
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of the study is to determine whether combined cataract and glaucoma surgery (phacotrabeculotomy)is more effective in lowering intraocular pressure than cataract surgery alone in patients with borderline control of intraocular pressure.

Registry

clinicaltrials.gov

Start Date

December 2004

End Date

June 2007

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medical University of Vienna

Eligibility Criteria

Inclusion Criteria

•Clinical Diagnosis of Primary Open Angle or Pseudoexfoliative Glaucoma and Cataract

Exclusion Criteria

•Other glaucoma than POAG or PEX-Glaucoma
•Medically uncontrolled Glaucoma:
•IOP \> 24 mmHg with two topical medications IOP \> 21 mmHg with three topical medications
•IOP \< 18 mmHg with two topical medications IOP \< 16 mmHg with three topical medications
•previous ocular surgery
•other ocular pathologies affecting visual acuity
•disorders of immune system

Outcomes

Primary Outcomes

Number of Patients with Constant Intraocular Pressure <18 mmHg with/without medication

Secondary Outcomes

Number of Patients with Constant Intraocular Pressure <18 mmHg without medication
Number of Patients with Constant Intraocular Pressure <21 mmHg with/without medication
Number of Patients needing surgical retreatment
Number of Patients with failure of surgical retreatment
Mean IOP after 1 and 2 years
Mean number of medication after 1 and 2 years
Number of intraoperative complications
comparison of postoperative complications between the groups
Visual acuity
decrease in perimetry