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Combined Phacotube vs Phacotrabeculectomy:A Randomized Controlled Trial
This study is currently recruiting participants.
Verified by National University Hospital, Singapore, May 2008
Sponsored by: National University Hospital, Singapore
Information provided by: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT00273221
  Purpose

The aim of this study is to compare the effectiveness and safety of combined phacoemulsification, posterior chamber intraocular lens implantation , trabeculectomy (phacotrabeculectomy) with phacoemulsification, intraocular lens implantation and glaucoma drainage device(phacotube) in the early and intermediate control of intraocular pressure(IOP) in patients with primary open angle and angle closure glaucoma.


Condition Intervention Phase
Glaucoma
Cataract
Procedure: Glaucoma Implant Surgery
Procedure: trabeculectomy
Procedure: phacoemulsification
Phase IV

Genetics Home Reference related topics: early-onset glaucoma
MedlinePlus related topics: Cataract Glaucoma
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Combined Phacoemulsification and Glaucoma Implant Surgery Versus Combined Phacoemulsification and Trabeculectomy: A Randomized Controlled Trial

Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • intraocular pressure(IOP).

Secondary Outcome Measures:
  • visual acuity,anterior chamber depth,visual field, glaucoma medication requirement, operative and post-operative complications and additional interventions(e.g.laser suture lysis, bleb

Estimated Enrollment: 50
Study Start Date: July 2005
Estimated Study Completion Date: July 2006
Detailed Description:

Studies have pointed out racial differences in the outcome of conventional filtration surgery. Glaucoma drainage implants have been found to do well in Asian eyes but no randomized controlled trial is available to support this claim. Objectives: It is the aim of this study to compare the effectiveness and safety of combined phacoemulsification, posterior chamber intraocular lens implantation , trabeculectomy (phacotrabeculectomy) versus phacoemulsification, intraocular lens implantation and glaucoma drainage device(phacotube) in the early and intermediate control of intraocular pressure(IOP) in patients with primary open angle and angle closure glaucoma. The secondary objective is to look into the post-operative complications encountered in phacotrabeculectomy and phacotube including the additional interventions (laser suture lysis, bleb needling, antimetabolite injections, etc.) applied in both procedures being studied Study Design. Randomized controlled trial. Methods. A total of 50 Asian subjects, 21 years old and above diagnosed with primary open/angle closure glaucoma, inadequately controlled by laser and medical treatment, with significant cataract and no previous eye surgery will be randomized to two types of combined procedures, phacotrabeculectomy and phacotube. Primary outcome measure is intraocular pressure and secondary outcome measures will be visual acuity, anterior chamber depth, visual field stability or progression, glaucoma medication requirement, operative and post-operative complications and additional, secondary interventions(e.g. laser suture lysis, bleb needling, 5-FU injections, anterior chamber reformation). All subjects will be followed up for a period of 1 year.This trial may define the role of GDI as a primary surgical option for Asian patients and the first randomized clinical trial in Asia to compare two combined procedures for glaucoma and cataract namely phacotrabeculectomy and phaco-glaucoma drainage implant surgery.﷡

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Ø 21 years old and above Ø Primary Open Angle Glaucoma with Shaffer grade 2 or better for 360 degrees Ø Primary Angle Closure Glaucoma (occludable angles +/- PAS) Ø Inadequate IOP control despite maximum medical treatment (using at least 2 types or more antiglaucoma medications) and/or laser treatment in the presence of glaucomatous optic neuropathy on optic nerve head evaluation and corresponding visual field findings Ø Visually significant cataract with visual acuity of less than or equal to 6/12 Ø No corneal disease Ø Willing to be followed up for 1 year duration post-operatively Ø Informed consent

Exclusion Criteria:

  • Ø Secondary Glaucoma (Uveitic, Neovascular, traumatic, Iridocorneal Endothelial Syndrome); Congenital Glaucoma Ø Severe ocular disease like Proliferative Diabetic Retinopathy, Age-related Macular Degeneration Exudative type Ø Prior intraocular surgery(in the study eye) Ø Patients with small central island and temporal field remaining on perimetry Ø One-eyed patients or fellow eye with visual acuity of counting fingers (CF) or worse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00273221

Contacts
Contact: Paul TC Chew, A/Prof. 67725317 ext 5317 ophchew@nus.edu.sg
Contact: Maria Cecilia D Aquino, MD 67725317 ext 5317 cel_aq@yahoo.com

Locations
Singapore
National University Hospital Recruiting
5 Lower Kent Ridge Road, Singapore, 119074
Contact: Paul TC Chew, A/Professor     67725317 ext 5317     ophchew@nus.edu.sg    
Contact: Maria Cecilia D Aquino, MD     67725317 ext 5317     cel_aq@yahoo.com    
Principal Investigator: Paul TC Chew, A/Prof            
Sub-Investigator: Maria Cecilia D Aquino, MD            
Sub-Investigator: Jovina L See, MD            
Sub-Investigator: Winifred Patricia Nolan, MD            
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Paul TC Chew, A/Prof National University Hospital, Singapore
  More Information

Study ID Numbers: DSRB-A/05/196
Study First Received: January 6, 2006
Last Updated: May 21, 2008
ClinicalTrials.gov Identifier: NCT00273221  
Health Authority: Singapore: Health Sciences Authority

Keywords provided by National University Hospital, Singapore:
Glaucoma
Cataract

Study placed in the following topic categories:
Glaucoma
Eye Diseases
Cataract
Lens Diseases
Hypertension
Ocular Hypertension

ClinicalTrials.gov processed this record on January 16, 2009