Partial Least Squares Regression Modelling for Glaucoma Detection

Glaucoma Clinical Trial

Official title:

Partial Least Squares Regression Modelling for Glaucoma Detection Using Retinal Nerve Fiber Layer, Ganglion Cell Layer and Visual Field Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03365245
• Other study ID #: PLSR
• Status: Completed
• Phase: N/A
• First received: November 4, 2017
• Last updated: December 1, 2017
• Start date: August 2015
• Est. completion date: November 2016

Study information

• Verified date: December 2017
• Source: Vienna Institute for Research in Ocular Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A partial least squares regression model for visual field testing among glaucoma patients will be developed.

In addition, microperimetry will be compared to conventional perimetry and reproducibility will be assessed.

Description:

Aim of this study is to develop a partial least squares regression model incorporating retinal nerve fiber layer (RNFL) and retinal ganglion cell layer (RGCL) measurements as well as visual field testing to represent a glaucoma expert opinion on the stage of glaucoma.

In addition, microperimetry will be compared to conventional perimetry and reproducibility will be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Age 21 and older

• written informed consent prior to surgery

• any glaucoma-associated changes in one or both eyes (i.e. increased intraocular pressure, optic disc changes, known visual field defects) in the "glaucoma patients" and the absence of any glaucoma associated changes in the "healthy eyes group".

Exclusion Criteria:

• Secondary glaucoma

• In case of pregnancy (pregnancy test will be taken in women of reproductive age)

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• Microperimetry
Microperimetry is performed at three different days
• automated visual field
Automated visual field ist performed at three different days

Locations

Country	Name	City	State
Austria	VIROS	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Vienna Institute for Research in Ocular Surgery

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	partial least square regression	Development of a partial least squares regression model to detect glaucoma	one month
Secondary	reproducibility	Comparison of reproducibility of microperimetry and visual field testing	one month
Secondary	Retinal nerve fiber thickness (RNFL) and the the retinal ganglion cell layer (RGCL)	The retinal nerve fiber layer thickness and the thickness of the retinal ganglion cell layer will be compared	one month
Secondary	Microperimetry versus visual field testing	Comparison of microperimetry and visual field testing	one month