NCT00346931

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2004

Typical duration for not_applicable

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

July 23, 2010

Status Verified

June 1, 2006

Enrollment Period

2.5 years

First QC Date

June 29, 2006

Last Update Submit

July 22, 2010

Conditions

Pseudoexfoliative GlaucomaPrimary Open Angle Glaucoma

Keywords

glaucomacataractsurgeryintraocular pressurephacoemulsificationtrabeculotomy

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Interventions

Phacoemulsification, implantation of intraocular lensPROCEDURE
Phacoemulsification, Implantation of IOL, trabeculotomyPROCEDURE

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glaucoma, Open-AngleGlaucomaCataract

Interventions

PhacoemulsificationLens Implantation, IntraocularTrabeculectomy

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesLens Diseases

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical ProceduresFiltering Surgery

Study Officials

  • Clemens Vass, Univ.Prof.Dr.med.univ.

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 29, 2006

First Posted

July 4, 2006

Study Start

December 1, 2004

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

July 23, 2010

Record last verified: 2006-06