NCT01247831

Brief Summary

The purpose of this study is to examine the influence of selective laser trabeculoplasty (SLT) on ocular rigidity in glaucoma patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2010

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 24, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

February 8, 2017

Status Verified

February 1, 2017

Enrollment Period

9 months

First QC Date

November 23, 2010

Last Update Submit

February 6, 2017

Conditions

Glaucoma

Keywords

glaucoma, selective laser trabeculoplasty, ocular rigidity

Outcome Measures

Primary Outcomes (1)

  • change in ocular rigidity

    Is there a change in ocular rigidity (corneal hysteresis, corneal resistance factor) as measured with the Ocular Response Analyzer (Reichert) after selective laser trabeculoplasty?

    4 weeks

Secondary Outcomes (1)

  • IOP reduction

    4 weeks

Study Arms (1)

glaucoma patients

OTHER

All of the patients treated with SLT need further IOP reduction for control of their glaucoma.

Procedure: Selective Laser Trabeculoplasty

Interventions

Selective Laser TrabeculoplastyPROCEDURE

100 spots with an energy of 0,8 mJ are applied over 360° of the trabecular meshwork of glaucoma patients with a Q-switched 532 nm frequency doubled neodymium YAG Laser.

Also known as: SLT, ORA
glaucoma patients

Eligibility Criteria

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

You may qualify if:

  • glaucoma patients (primary open angle glaucoma, ocular hypertension) over the age of 18 who need further IOP reduction to control their glaucoma

You may not qualify if:

  • other forms of glaucoma (angle closure, secondary glaucoma, congenital, juvenile), acute psychosis, epilepsy

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 Hornykewycz, MD

    University Eye Clinic Dresden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principla Investigator

Study Record Dates

First Submitted

November 23, 2010

First Posted

November 24, 2010

Study Start

November 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

February 8, 2017

Record last verified: 2017-02

Locations

DE(1)