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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

Tracking Information
First Submitted Date May 14, 2014
First Posted Date May 19, 2014
Last Update Posted Date May 19, 2014
Study Start Date August 2013
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 16, 2014)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Posterior Pole Asymmetry Analysis (PPAA) for Early Glaucoma
Official Title Diagnostic Ability of Posterior Pole Asymmetry Analysis Parameters (PPAA) of Spectralis Optical Coherence Tomography (OCT) in Detecting Early Glaucoma
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Glaucoma
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 16, 2014)
156
Original Actual Enrollment Same as current
Actual Study Completion Date March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 49 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries India
Removed Location Countries  
 
Administrative Information
NCT Number NCT02141594
Other Study ID Numbers OCT PPAA in early glaucoma
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Paaraj Dave, Dr T V Patel Eye Institute
Study Sponsor Dr T V Patel Eye Institute
Collaborators Not Provided
Investigators
Principal Investigator: Paaraj R Dave, MS Dr TV Patel Eye Institute
PRS Account Dr T V Patel Eye Institute
Verification Date May 2014