Posterior Pole Asymmetry Analysis (PPAA) for Early Glaucoma (PPAA)

May 16, 2014 updated by: Paaraj Dave, Dr T V Patel Eye Institute

Diagnostic Ability of Posterior Pole Asymmetry Analysis Parameters (PPAA) of Spectralis Optical Coherence Tomography (OCT) in Detecting Early Glaucoma

Spectrailis optical coherence tomography has come with a new posterior pole asymmetry analysis for glaucoma diagnosis. The aim of the investigators study was to assess its applicability in diagnosing early glaucoma patients.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Gujarat
      • Vadodara, Gujarat, India, 390001
        • Dr TV Patel Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

49 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive 80 eyes of 80 normal subjects and 76 eyes of 76 patients with early glaucoma were included for the study.

Description

Inclusion Criteria:

  • Age more than 18 years
  • Best corrected visual acuity 20/40 or better
  • Refractive error within ±5D sphere and ±3D cylinder
  • Willingness to participate in the study

Exclusion Criteria:

  • Media opacities preventing imaging
  • Intraocular surgery within the last 6 months
  • Any retinal or neurological disease other than glaucoma that could confound the results of visual field examination and OCT.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Early glaucoma
The study group consisted of consecutive unilateral glaucoma patients, categorized as early stage by Hodapp-Anderson-Parrish classification.
Normal subjects
Normal control subjects had a normal ocular examination, Intraocular pressure (IOP) <22 mmHg, no past history of high IOP, no family history of glaucoma, normal optic disc morphology and visual field in both eyes. One eye of control subject was randomly selected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under curve for all the diagnostic parameters of optical coherence tomography
Time Frame: up to 32 weeks
This was a cross sectional study with one time measurement of the diagnostic parameters of the optical coherence tomography.
up to 32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr T V Patel Eye Institute

Investigators

  • Principal Investigator: Paaraj R Dave, MS, Dr TV Patel Eye Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

May 14, 2014

First Submitted That Met QC Criteria

May 16, 2014

First Posted (Estimate)

May 19, 2014

Study Record Updates

Last Update Posted (Estimate)

May 19, 2014

Last Update Submitted That Met QC Criteria

May 16, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCT PPAA in early glaucoma

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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