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Re-Trabeculectomy Versus Ahmed Glaucoma Valve Implantation in Secondary Surgical Management of Patients With Refractory Glaucoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nariman Nassiri, Vanak Eye Surgery Center
ClinicalTrials.gov Identifier:
NCT01633775
First received: June 29, 2012
Last updated: July 3, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Refractory Primary Open Angle Glaucoma
 Procedure: Implantation of Ahmed glaucoma tube shunt, and Trabeculectomy with MMC

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Re-Trabeculectomy Versus Ahmed Glaucoma Valve Implantation in Secondary Surgical Management of Patients With Refractory Primary Open Angle Glaucoma: a Three-year Comparative Study

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by Vanak Eye Surgery Center:

Primary Outcome Measures:
  • Change in target intraocular pressure (IOP) [ Time Frame: day 1, week 1, months 1,3,6,9,12,18,24,30,36 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of anit-glaucoma medications [ Time Frame: day 1, week 1, months 1,3,6,9,12,18,24,30,36 ] [ Designated as safety issue: No ]
  • Visual Acuity [ Time Frame: day 1, week 1, months 1,3,6,9,12,18,24,30,36 ] [ Designated as safety issue: No ]
  • Mean deviation of visual field exam [ Time Frame: Months 6,12,18,24,30,36 ] [ Designated as safety issue: No ]
    Only visual field results where consecutive field tests did not show an improvement of 2 dB or more in the mean deviation (MD) over the baseline reading were included as we considered the phenomenon of learning effect in our analysis.

  • Surgical Success [ Time Frame: day 1, week 1, months 1,3,6,9,12,18,24,30,36 ] [ Designated as safety issue: Yes ]
    Surgical failure was defined as persistent IOP of more than target pressure on maximally tolerated medications or IOP less than 6 mm Hg on two consecutive visits, phthisis bulbi, reduction of vision to no light perception, removal of the shunt implant, reoperation for glaucoma, or any devastating intraoperative and postoperative complications.


Enrollment: 100
Study Start Date: December 2007
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ahmed glaucoma implant Procedure: Implantation of Ahmed glaucoma tube shunt, and Trabeculectomy with MMC
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.
Trabeculectomy with mitomycin C (MMC) Procedure: Implantation of Ahmed glaucoma tube shunt, and Trabeculectomy with MMC
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.

Detailed Description:

Currently, lowering intraocular pressure (IOP) is the only treatment modality to prevent or slow progression of glaucomatous optic nerve damage. Incisional procedures are indicated when medical therapy and/or laser procedures cannot adequately reduce IOP. Trabeculectomy is the most common glaucoma incisional procedure globally. On the other hand, glaucoma drainage devices that have been historically reserved for cases of glaucoma deemed at high risk of failure have increasingly gained popularity particularly in eyes with previous history of glaucoma surgery.

There is still no agreement on the appropriate surgical procedure in those with prior glaucoma surgery. The five-year tube versus trabeculectomy (TVT) study, which evaluated the efficacy and safety of Baerveldt glaucoma implant versus trabeculectomy, showed that both surgical procedures had similar IOP reduction and use of anti-glaucoma medication; tube shunt surgery had a higher success rate than trabeculectomy with mitomycin C (MMC); the trabeculectomy/MMC had higher incidence of early postoperative complications compared to tube shunt surgery; and rates of late postoperative complications, reoperation for complications, and cataract extraction were comparable in both treatment groups.

In this study, the investigators compared three-year outcomes of re-trabeculectomy with those of Ahmed glaucoma valve implantation in secondary surgical management of patients with primary open angle glaucoma and a previous history of failed trabeculectomy.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633775

Locations
Iran, Islamic Republic of
Imam Hossein Medical Center
Tehran, Iran, Islamic Republic of
Negah Eye Hospital
Tehran, Iran, Islamic Republic of
Vanak Eye Surgery Center
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Vanak Eye Surgery Center
Investigators
Principal Investigator: Nariman Nassiri, MD, MPH Vanak Eye Surgery Center
  More Information

Additional Information:
Primary Open Angle Glaucoma Preferred Practice Pattern  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Nariman Nassiri, Prinicpal Investigator, Vanak Eye Surgery Center
ClinicalTrials.gov Identifier: NCT01633775     History of Changes
Other Study ID Numbers: VESC#2007-056
Study First Received: June 29, 2012
Last Updated: July 3, 2012
Health Authority: Iran: Ethics Committee

Keywords provided by Vanak Eye Surgery Center:
Refractory primary open angle glaucoma
trabeculectomy
ahmed valve implant

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on June 18, 2013