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NCT00346931 Clinical Trial

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

Primary Open Angle Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00346931
Other study ID # CCI-PTO-2004-AKH
Secondary ID
Status Terminated
Phase N/A
First received June 29, 2006
Last updated July 22, 2010
Start date December 2004
Est. completion date June 2007

Study information
Verified date June 2006
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Phacoemulsification, implantation of intraocular lens

• Phacoemulsification, Implantation of IOL, trabeculotomy

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Vienna

Outcome
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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