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Trial record 77 of 1615 for:    glaucoma

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

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ClinicalTrials.gov Identifier: NCT02141594
Recruitment Status : Completed
First Posted : May 19, 2014
Last Update Posted : May 19, 2014
Sponsor:
Information provided by (Responsible Party):
Paaraj Dave, Dr T V Patel Eye Institute

Brief Summary:
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.

Condition or disease
Glaucoma

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Study Type : Observational
Actual Enrollment : 156 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Diagnostic Ability of Posterior Pole Asymmetry Analysis Parameters (PPAA) of Spectralis Optical Coherence Tomography (OCT) in Detecting Early Glaucoma
Study Start Date : August 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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.



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   49 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02141594


Locations
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India
Dr TV Patel Eye Institute
Vadodara, Gujarat, India, 390001
Sponsors and Collaborators
Dr T V Patel Eye Institute
Investigators
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Principal Investigator: Paaraj R Dave, MS Dr TV Patel Eye Institute

Publications of Results:
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Responsible Party: Paaraj Dave, Dr, Dr T V Patel Eye Institute
ClinicalTrials.gov Identifier: NCT02141594     History of Changes
Other Study ID Numbers: OCT PPAA in early glaucoma
First Posted: May 19, 2014    Key Record Dates
Last Update Posted: May 19, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases