NCT01633775

Brief Summary

The purpose of this study is to compare three-year outcomes of re-trabeculectomy with those of Ahmed glaucoma valve implantation in secondary surgical management of patients with primary open angle glaucoma (POAG) and a history of previous failed trabeculectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2007

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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, 2007

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 4, 2012

Completed
Last Updated

July 4, 2012

Status Verified

June 1, 2012

Enrollment Period

4.1 years

First QC Date

June 29, 2012

Last Update Submit

July 3, 2012

Conditions

Refractory Primary Open Angle Glaucoma

Keywords

Refractory primary open angle glaucomatrabeculectomyahmed valve implant

Outcome Measures

Primary Outcomes (1)

  • Change in target intraocular pressure (IOP)

    All patients had a target IOP that had been assigned for them by the same surgeon prior to their initial failed trabeculectomy/MMC. The routine practice of the surgeon has been to set target IOP based on the Best Practice Treatment Algorithm for POAG. This was based on at least 25% reduction in baseline IOP. Target IOP needs constant reevaluation during the follow-up based on disease progression. In our study, success and failure were considered to be assessed based on change in the target pressure.

    day 1, week 1, months 1,3,6,9,12,18,24,30,36

Secondary Outcomes (4)

  • Number of anit-glaucoma medications

    day 1, week 1, months 1,3,6,9,12,18,24,30,36

  • Visual Acuity

    day 1, week 1, months 1,3,6,9,12,18,24,30,36

  • Mean deviation of visual field exam

    Months 6,12,18,24,30,36

  • Surgical Success

    day 1, week 1, months 1,3,6,9,12,18,24,30,36

Study Arms (2)

Ahmed glaucoma implant

Procedure: Implantation of Ahmed glaucoma tube shunt, and Trabeculectomy with MMC

Trabeculectomy with mitomycin C (MMC)

Procedure: Implantation of Ahmed glaucoma tube shunt, and Trabeculectomy with MMC

Interventions

Implantation of Ahmed glaucoma tube shunt, and Trabeculectomy with MMCPROCEDURE

In the Ahmed implant group, the tube shunts used were the valved 184-mm2 surface area (Model FP7; New World Medical, Inc, Rancho Cucamonga, California, USA). In the Trabeculectomy group, a routine trabeculectomy surgery was performed.

Ahmed glaucoma implantTrabeculectomy with mitomycin C (MMC)

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with refractory primary open angle glaucoma and a history of failed trabeculectomy with mitomycin C (MMC).

You may qualify if:

  • Uncontrolled glaucoma defined as (1) IOP not achieving previously assigned target pressure despite prior trabeculectomy and use of maximally tolerated anti-glaucoma medication; and (2) recent progression of the disease based on glaucomatous changes in optic disc appearance and/or worsening of the visual field exam.
  • In the case of two eligible eyes, only the first eye being operated on was enrolled

You may not qualify if:

  • Younger than 40 years old
  • Visual acuity of no light perception
  • Lens opacity
  • Elevated IOP associated with silicone oil
  • Prior ocular surgeries other than one trabeculectomy with MMC
  • Previous cyclodestructive treatment
  • Increased risk of endophthalmitis
  • Posterior segment disorders
  • Pre-existing ocular comorbidities (e.g. pterygium,phacodonesis,corneal opacity, or corneal endothelial dystrophies)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Imam Hossein Medical Center

Tehran, Iran

Location

Negah Eye Hospital

Tehran, Iran

Location

Vanak Eye Surgery Center

Tehran, Iran

Location

Related Publications (14)

  • Ramulu PY, Corcoran KJ, Corcoran SL, Robin AL. Utilization of various glaucoma surgeries and procedures in Medicare beneficiaries from 1995 to 2004. Ophthalmology. 2007 Dec;114(12):2265-70. doi: 10.1016/j.ophtha.2007.02.005. Epub 2007 Apr 27.

    PMID: 17466376BACKGROUND

  • Chen PP, Yamamoto T, Sawada A, Parrish RK 2nd, Kitazawa Y. Use of antifibrosis agents and glaucoma drainage devices in the American and Japanese Glaucoma Societies. J Glaucoma. 1997 Jun;6(3):192-6.

    PMID: 9211144BACKGROUND

  • Joshi AB, Parrish RK 2nd, Feuer WF. 2002 survey of the American Glaucoma Society: practice preferences for glaucoma surgery and antifibrotic use. J Glaucoma. 2005 Apr;14(2):172-4. doi: 10.1097/01.ijg.0000151684.12033.4d.

    PMID: 15741822BACKGROUND

  • Gedde SJ, Schiffman JC, Feuer WJ, Parrish RK 2nd, Heuer DK, Brandt JD; Tube Versus Trabeculectomy Study Group. The tube versus trabeculectomy study: design and baseline characteristics of study patients. Am J Ophthalmol. 2005 Aug;140(2):275-87. doi: 10.1016/j.ajo.2005.03.031.

    PMID: 16086949BACKGROUND

  • Gedde SJ, Schiffman JC, Feuer WJ, Herndon LW, Brandt JD, Budenz DL. Treatment outcomes in the tube versus trabeculectomy study after one year of follow-up. Am J Ophthalmol. 2007 Jan;143(1):9-22. doi: 10.1016/j.ajo.2006.07.020. Epub 2006 Sep 1.

    PMID: 17083910BACKGROUND

  • Gedde SJ, Herndon LW, Brandt JD, Budenz DL, Feuer WJ, Schiffman JC. Surgical complications in the Tube Versus Trabeculectomy Study during the first year of follow-up. Am J Ophthalmol. 2007 Jan;143(1):23-31. doi: 10.1016/j.ajo.2006.07.022. Epub 2006 Sep 1.

    PMID: 17054896BACKGROUND

  • Gedde SJ, Schiffman JC, Feuer WJ, Herndon LW, Brandt JD, Budenz DL; Tube Versus Trabeculectomy Study Group. Three-year follow-up of the tube versus trabeculectomy study. Am J Ophthalmol. 2009 Nov;148(5):670-84. doi: 10.1016/j.ajo.2009.06.018. Epub 2009 Aug 11.

    PMID: 19674729BACKGROUND

  • Gedde SJ, Schiffman JC, Feuer WJ, Herndon LW, Brandt JD, Budenz DL; Tube versus Trabeculectomy Study Group. Treatment outcomes in the Tube Versus Trabeculectomy (TVT) study after five years of follow-up. Am J Ophthalmol. 2012 May;153(5):789-803.e2. doi: 10.1016/j.ajo.2011.10.026. Epub 2012 Jan 15.

    PMID: 22245458BACKGROUND

  • Gedde SJ, Herndon LW, Brandt JD, Budenz DL, Feuer WJ, Schiffman JC; Tube Versus Trabeculectomy Study Group. Postoperative complications in the Tube Versus Trabeculectomy (TVT) study during five years of follow-up. Am J Ophthalmol. 2012 May;153(5):804-814.e1. doi: 10.1016/j.ajo.2011.10.024. Epub 2012 Jan 14.

    PMID: 22244522BACKGROUND

  • Serle J, Cantor L, Gross R, Katz J, Mundorf T, Noecker R, Severin T, Simmons S, Walt J, Casciano J, Evans S, Doyle J. Best practice treatment algorithm for primary open-angle glaucoma: implications for U.S. ophthalmology practice. Manag Care Interface. 2002 Jul;15(7):37-48.

    PMID: 12143296BACKGROUND

  • Huang MC, Netland PA, Coleman AL, Siegner SW, Moster MR, Hill RA. Intermediate-term clinical experience with the Ahmed Glaucoma Valve implant. Am J Ophthalmol. 1999 Jan;127(1):27-33. doi: 10.1016/s0002-9394(98)00394-8.

    PMID: 9932995BACKGROUND

  • Wilson MR, Mendis U, Smith SD, Paliwal A. Ahmed glaucoma valve implant vs trabeculectomy in the surgical treatment of glaucoma: a randomized clinical trial. Am J Ophthalmol. 2000 Sep;130(3):267-73. doi: 10.1016/s0002-9394(00)00473-6.

    PMID: 11020403BACKGROUND

  • Topouzis F, Coleman AL, Choplin N, Bethlem MM, Hill R, Yu F, Panek WC, Wilson MR. Follow-up of the original cohort with the Ahmed glaucoma valve implant. Am J Ophthalmol. 1999 Aug;128(2):198-204. doi: 10.1016/s0002-9394(99)00080-x.

    PMID: 10458176BACKGROUND

  • Wilson MR, Mendis U, Paliwal A, Haynatzka V. Long-term follow-up of primary glaucoma surgery with Ahmed glaucoma valve implant versus trabeculectomy. Am J Ophthalmol. 2003 Sep;136(3):464-70. doi: 10.1016/s0002-9394(03)00239-3.

    PMID: 12967799BACKGROUND

Related Links

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Filtering SurgeryOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Nariman Nassiri, MD, MPH

    Vanak Eye Surgery Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicpal Investigator

Study Record Dates

First Submitted

June 29, 2012

First Posted

July 4, 2012

Study Start

December 1, 2007

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

July 4, 2012

Record last verified: 2012-06

Locations

IR(3)