NCT01741961

Brief Summary

Long term results after Ahmed glaucoma valve implantation for uncontrolled glaucoma are retrospectively examined.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
214

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2006

Longer than P75 for all trials

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

June 1, 2006

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 5, 2012

Completed
Last Updated

December 5, 2012

Status Verified

December 1, 2012

Enrollment Period

6.3 years

First QC Date

November 22, 2012

Last Update Submit

December 3, 2012

Conditions

Glaucoma

Keywords

uncontrolled glaucomaglaucoma drainage device

Outcome Measures

Primary Outcomes (1)

  • intraocular pressure reduction

    The reduction of intraocular pressure after Ahmed glaucoma valve implantation is observed over a period of 4 years.

    4 years

Secondary Outcomes (1)

  • development of visual acuity

    4 years

Other Outcomes (3)

  • reduction of glaucoma medication

    4 years

  • postoperative complications

    4 years

  • need for revision operation

    4 years

Study Arms (1)

glaucoma, surgery, Ahmed valve

Patients with uncontrolled glaucoma undergoing Ahmed glaucoma valve implantation for intraocular pressure reduction.

Procedure: Ahmed valve

Interventions

Ahmed valvePROCEDURE

The flexible plate 7 (FP7) model (New World Medical) was implanted in patients with uncontrolled glaucoma.

glaucoma, surgery, Ahmed valve

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients suffering from uncontrolled glaucoma, most often after multiple ocular surgery.

You may qualify if:

  • Patients suffering from medically uncontrolled glaucoma
  • Informed consent

You may not qualify if:

  • healthy subjects
  • under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Eye Clinic Dresden

Dresden, Saxony, 01307, Germany

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Karin R Pillunat, MD

    University Dresden, Eye Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 22, 2012

First Posted

December 5, 2012

Study Start

June 1, 2006

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

December 5, 2012

Record last verified: 2012-12

Locations

DE(1)