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

Medical University of Vienna9 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Open Angle Glaucoma Pseudoexfoliative Glaucoma

Interventions

Phacoemulsification, implantation of intraocular lensPROCEDURE

Phacoemulsification, Implantation of IOL, trabeculotomyPROCEDURE

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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