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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00346931
Enrollment
9
Registered
2006-07-04
Start date
2004-12-31
Completion date
2007-06-30
Last updated
2010-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Open Angle Glaucoma, Pseudoexfoliative Glaucoma

Keywords

glaucoma, cataract, surgery, intraocular pressure, phacoemulsification, trabeculotomy

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.

Interventions

PROCEDUREPhacoemulsification, implantation of intraocular lens
PROCEDUREPhacoemulsification, Implantation of IOL, trabeculotomy

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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
Number of Patients with Constant Intraocular Pressure <18 mmHg without medication
Number of intraoperative complications
comparison of postoperative complications between the groups
Visual acuity
decrease in perimetry
Mean number of medication after 1 and 2 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026