NCT01883856

Brief Summary

The purpose of this study is to evaluate and compare the clinical outcomes after implantation of the porous plate (polyethylene) (Model M4) Ahmed Glaucoma Valve with the silicone plate Ahmed Glaucoma Valve (Model FP7) in participants with refractory glaucoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

February 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 21, 2013

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2017

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2018

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

September 18, 2020

Completed
Last Updated

October 19, 2020

Status Verified

September 1, 2020

Enrollment Period

5.6 years

First QC Date

June 18, 2013

Results QC Date

August 25, 2020

Last Update Submit

September 21, 2020

Conditions

Glaucoma

Keywords

Refractory GlaucomaIntractable GlaucomaPrimary Open Angle GlaucomaNeovascular Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Change in Intraocular Pressure

    The primary endpoint is the mean intraocular pressure in the porous plate group as compared to the silicone plate group.

    12 months

Secondary Outcomes (2)

  • Anti-Glaucoma Medications

    12 months

  • Surgical Success

    12 months

Study Arms (2)

Silicone Plate Ahmed Glaucoma Valve

ACTIVE COMPARATOR

Silicone plate Ahmed Glaucoma Valve

Device: Silicone plate Ahmed Glaucoma Valve (Model FP7)

Porous Plate Ahmed Glaucoma Valve

EXPERIMENTAL

Porous Plate Ahmed Glaucoma Valve

Device: Porous Plate Ahmed Glaucoma Valve (Model M4)

Interventions

Silicone plate Ahmed Glaucoma Valve (Model FP7)DEVICE

This intervention is conducted as a surgical intervention.

Silicone Plate Ahmed Glaucoma Valve
Porous Plate Ahmed Glaucoma Valve (Model M4)DEVICE

This intervention is conducted as a surgical intervention.

Porous Plate Ahmed Glaucoma Valve

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female of any race ≥ 18 years and ≤ 80 years of age.
  • Diagnosis of intractable glaucoma in the study eye, with the exception of silicone oil endotamponade induced glaucoma, which has not responded to conventional medical and surgical therapy.
  • Elevated intraocular pressure \> 21 mmHg in the study eye. Two consecutive measurements using Goldmann Applanation Tonometry will be obtained and the mean of those two measurements will be considered the subject's baseline intraocular pressure.
  • Subject is a candidate for surgery in the study eye with a glaucoma drainage device.
  • Subject is willing and able to sign the informed consent.

You may not qualify if:

  • Diagnosis of silicone oil endotamponade induced glaucoma in the study eye.
  • History of prior drainage implant surgery in the study eye.
  • History of cyclophotocoagulation of the study eye.
  • Pregnancy.
  • Prisoner.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

  • Roa TM, Netland PA, Costa VP, Sarkisian SR Jr, Al-Aswad LA, Moster MR, Ahmed IIK. Comparison of Silicone- and Porous-Plate Ahmed Glaucoma Valves. Med Devices (Auckl). 2020 Jul 16;13:213-221. doi: 10.2147/MDER.S258498. eCollection 2020.

    PMID: 32765127RESULT

Related Links

MeSH Terms

Conditions

GlaucomaGlaucoma, Open-AngleGlaucoma, Neovascular

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Results Point of Contact

Title
Peter A. Netland, MD, PhD
Organization
University of Virginia
pan9c@virginia.edu
4349821086

Study Officials

  • Peter A Netland, MD, PhD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chair, Department of Ophthalmology

Study Record Dates

First Submitted

June 18, 2013

First Posted

June 21, 2013

Study Start

February 1, 2012

Primary Completion

September 10, 2017

Study Completion

August 27, 2018

Last Updated

October 19, 2020

Results First Posted

September 18, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Described in study results - https://pubmed.ncbi.nlm.nih.gov/32765127/

Locations

US(1)