Combined Phacotube vs Phacotrabeculectomy:A Randomized Controlled Trial

Combined Phacoemulsification and Glaucoma Implant Surgery Versus Combined Phacoemulsification and Trabeculectomy: A Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Glaucoma; Cataract
• Intervention / Treatment: Procedure: trabeculectomy; Procedure: Glaucoma Implant Surgery; Procedure: phacoemulsification

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.﷡

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Singapore
  • 5 Lower Kent Ridge Road, Singapore, 119074
    • Recruiting
    • National University Hospital
    • Contact: Maria Cecilia D Aquino, MD; Phone Number: 5317 67725317; Email: cel_aq@yahoo.com
    • Contact: Paul TC Chew, A/Professor; Phone Number: 5317 67725317; Email: ophchew@nus.edu.sg
    • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
intraocular pressure(IOP).

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National University Hospital, Singapore
• Investigators: Principal Investigator: Paul TC Chew, A/Prof, National University Hospital, Singapore

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Study Completion (Anticipated): July 1, 2006

Study Registration Dates

• First Submitted: January 6, 2006
• First Submitted That Met QC Criteria: January 6, 2006
• First Posted (Estimate): January 9, 2006

Study Record Updates

• Last Update Posted (Estimate): May 22, 2008
• Last Update Submitted That Met QC Criteria: May 21, 2008
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: Cataract; Glaucoma
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Lens Diseases; Glaucoma; Cataract
• Other Study ID Numbers: DSRB-A/05/196