Partial Least Squares Regression Modelling for Glaucoma Detection

• Sponsor: Vienna Institute for Research in Ocular Surgery (Other)
• Overall Status: Completed
• CT.gov ID: NCT03365245
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Arm: 1
• Duration (Months): 15
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Device: Microperimetry; Device: automated visual field	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Partial Least Squares Regression Modelling for Glaucoma Detection Using Retinal Nerve Fiber Layer, Ganglion Cell Layer and Visual Field Data
• Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: Nov 1, 2016
• Actual Study Completion Date: Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: study arm Microperimetry and automated visual field are performed at three different days	Device: Microperimetry; Microperimetry is performed at three different days; Device: automated visual field; Automated visual field ist performed at three different days

Outcome Measures

Primary Outcome Measures

1. partial least square regression [one month]

   Development of a partial least squares regression model to detect glaucoma

Secondary Outcome Measures

1. reproducibility [one month]

   Comparison of reproducibility of microperimetry and visual field testing

2. Retinal nerve fiber thickness (RNFL) and the the retinal ganglion cell layer (RGCL) [one month]

   The retinal nerve fiber layer thickness and the thickness of the retinal ganglion cell layer will be compared

3. Microperimetry versus visual field testing [one month]

   Comparison of microperimetry and visual field testing

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VIROS	Vienna		Austria	1140

Sponsors and Collaborators

• Vienna Institute for Research in Ocular Surgery

Investigators

• Principal Investigator: Oliver Findl, MD, Vienna Institute for Research in Ocular Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prim. Prof. Dr. Oliver Findl, MBA, Principal Investigator, Vienna Institute for Research in Ocular Surgery
• ClinicalTrials.gov Identifier: NCT03365245
• Other Study ID Numbers: PLSR
• First Posted: Dec 7, 2017
• Last Update Posted: Dec 7, 2017
• Last Verified: Dec 1, 2017

• Additional relevant MeSH terms: Glaucoma

Study Results

No Results Posted as of Dec 7, 2017