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Combined Phacotube vs Phacotrabeculectomy:A Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT00273221
Recruitment Status : Unknown
Verified May 2008 by National University Hospital, Singapore.
Recruitment status was:  Recruiting
First Posted : January 9, 2006
Last Update Posted : May 22, 2008
Sponsor:
Information provided by:
National University Hospital, Singapore

Brief 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.

Condition or disease Intervention/treatment Phase
Glaucoma Cataract Procedure: Glaucoma Implant Surgery Procedure: trabeculectomy Procedure: phacoemulsification Phase 4

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.﷡

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Phacoemulsification and Glaucoma Implant Surgery Versus Combined Phacoemulsification and Trabeculectomy: A Randomized Controlled Trial
Study Start Date : July 2005
Estimated Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Glaucoma




Primary Outcome Measures :
  1. intraocular pressure(IOP).

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


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00273221


Contacts
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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
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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
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Principal Investigator: Paul TC Chew, A/Prof National University Hospital, Singapore

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ClinicalTrials.gov Identifier: NCT00273221     History of Changes
Other Study ID Numbers: DSRB-A/05/196
First Posted: January 9, 2006    Key Record Dates
Last Update Posted: May 22, 2008
Last Verified: May 2008
Keywords provided by National University Hospital, Singapore:
Glaucoma
Cataract
Additional relevant MeSH terms:
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Glaucoma
Cataract
Ocular Hypertension
Eye Diseases
Lens Diseases