Combined Phacotube vs Phacotrabeculectomy:A Randomized Controlled Trial

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00273221
• Other study ID #: DSRB-A/05/196
• Status: Recruiting
• Phase: Phase 4
• First received: January 6, 2006
• Last updated: May 21, 2008
• Start date: July 2005
• Est. completion date: July 2006

Study information

• Verified date: May 2008
• Source: National University Hospital, Singapore
• Contact: Paul TC Chew, A/Prof.
• Phone: 67725317
• Email: ophchew[@]nus.edu.sg
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial Summary

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.

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.﷡

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Glaucoma

Intervention

Procedure:
• Glaucoma Implant Surgery

• trabeculectomy

• phacoemulsification

Locations

Country	Name	City	State
Singapore	National University Hospital	5 Lower Kent Ridge Road

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraocular pressure(IOP).
Secondary	visual acuity,anterior chamber depth,visual field, glaucoma medication requirement, operative and post-operative complications and additional interventions(e.g.laser suture lysis, bleb