Primary Open Angle Glaucoma Clinical Trial
Official title:
Phacotrabeculotomy vs. CCI+Phaco in Patients With Borderline Control of Intraocular Pressure
Verified date | June 2006 |
Source | Medical University of Vienna |
Contact | n/a |
Is FDA regulated | No |
Health authority | Austria: Ethikkommission |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 9 |
Est. completion date | June 2007 |
Est. primary completion date | June 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Patients with Constant Intraocular Pressure <18 mmHg with/without medication | |||
Secondary | Number of Patients with Constant Intraocular Pressure <18 mmHg without medication | |||
Secondary | Number of Patients with Constant Intraocular Pressure <21 mmHg with/without medication | |||
Secondary | Number of Patients needing surgical retreatment | |||
Secondary | Number of Patients with failure of surgical retreatment | |||
Secondary | Mean IOP after 1 and 2 years | |||
Secondary | Mean number of medication after 1 and 2 years | |||
Secondary | Number of intraoperative complications | |||
Secondary | comparison of postoperative complications between the groups | |||
Secondary | Visual acuity | |||
Secondary | decrease in perimetry |
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