NCT00382395

Brief Summary

Study Objective: To establish the substantial equivalence of the SOLX Gold Shunt to commercially available aqueous shunts, specifically the Ahmed™ Glaucoma Valve Model FP7, in the ability to reduce intraocular pressure (IOP) associated with glaucoma in eyes where medical and conventional surgical treatments have failed.

Trial Health

40
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2005

Longer than P75 for phase_3

Geographic Reach
5 countries

15 active sites

Status
suspended

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

November 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2006

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

September 18, 2015

Status Verified

September 1, 2015

Enrollment Period

11.7 years

First QC Date

September 27, 2006

Last Update Submit

September 17, 2015

Conditions

GlaucomaGlaucoma, Open Angle

Keywords

Glaucoma shuntOcular implantGoldtrabeculectomy

Outcome Measures

Primary Outcomes (1)

  • Percentage reduction in IOP at both 12 and 24 months after implant

    1 & 2 years

Secondary Outcomes (3)

  • Absolute IOP

    1 & 2 years

  • Mean number of glaucoma medications

    1 & 2 years

  • Success rate

    1 & 2 years

Study Arms (2)

1

EXPERIMENTAL

SOLX Gold Shunt

Device: SOLX Gold Shunt GMS-plus

2

ACTIVE COMPARATOR

Control Ahmed FP7 Shunt

Device: Ahmed FP7 Glaucoma Valve

Interventions

SOLX Gold Shunt GMS-plusDEVICE

Single use implant

1
Ahmed FP7 Glaucoma ValveDEVICE

Single use implant

2

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary open-angle, pseudoexfoliative, or pigmentary glaucoma
  • Age 21 or over
  • refractory glaucoma, with IOP \>21 mmHg on medications and failed prior incisional glaucoma surgery
  • detectable visual field defect (negative MD score)
  • written consent
  • available for up to 24 months follow-up

You may not qualify if:

  • either eye with VA worse than count fingers
  • recent angle closure glaucoma episode
  • uveitic glaucoma, iridocorneal endothelial (ICE) syndrome, traumatic glaucoma, or neovascular glaucoma
  • other significant ocular disease, except cataract
  • active ocular infection
  • expected ocular surgery in next 12 months
  • no suitable quadrant for implant
  • systemic corticosteroid therapy \> 5 mg/day prednisone
  • intolerance to gonioscopy or other eye exams
  • mental impairment interfering with consent or compliance
  • pregnancy
  • known sensitivity to anticipated medications used at surgery
  • significant co-morbid disease
  • concurrent enrollment in another drug or device study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

North Bay Eye Associates

Petaluma, California, 94954, United States

Location

Glaucoma Consultants of Colorado

Littleton, Colorado, 80120, United States

Location

International Eye Care

Tampa, Florida, 33603, United States

Location

Price Vision Group

Indianapolis, Indiana, 46260, United States

Location

University of Medicine and Dentistry of New Jersey

Newark, New Jersey, 07103, United States

Location

Glaucoma Associates of New York

New York, New York, 10003, United States

Location

Eagle Mountain Vision

Tulsa, Oklahoma, 74132, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Tennessee / Hamilton Eye Institute

Memphis, Tennessee, 38163, United States

Location

Credit Valley EyeCare

Mississauga, Ontario, L5L 1W8, Canada

Location

Institut du Glaucome de Montréal

Montreal, Quebec, H1V 1G5, Canada

Location

Bombay City Eye Institute & Research Centre

Mumbai, Maharashtra, 400 007, India

Location

Vision Research Foundation / Sankara Nethralaya

Chennai, Tamil Nadu, 600 006, India

Location

Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

Military Institute of the Health Services

Warsaw, 09-909, Poland

Location

MeSH Terms

Conditions

GlaucomaGlaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Jan S. Peterson, MS, RAC

    The Emmes Company, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 27, 2006

First Posted

September 29, 2006

Study Start

November 1, 2005

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

September 18, 2015

Record last verified: 2015-09

Locations

IL(1)IN(2)PL(1)CA(2)US(9)