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Relation Between Macular and RNFL Thickness Measurement and Quality Grading in OCT

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ClinicalTrials.gov Identifier: NCT02700750
Recruitment Status : Unknown
Verified March 2016 by Ori Segal, Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 7, 2016
Last Update Posted : March 7, 2016
Sponsor:
Information provided by (Responsible Party):
Ori Segal, Meir Medical Center

Brief Summary:

The investigators will enroll and scan normal eyes of healthy individuals using the Spectralis OCT. Each scan is graded on a scale of 0-40, with 0 representing the lowest quality and 40 the best possible one. Each of the participants will be scanned numerous times using this noninvasive imaging tool, while trying to get as many scans as possible of different quality. The differences in the parameters between the scans will then be recoded.

Collected data will include age, sex, subjects' refractive status, visual acuity, full slit lamp exam and the participants' OCT characteristics and measurements.


Condition or disease Intervention/treatment Phase
Nerve Fiber Bundle Defect Device: OCT exam Not Applicable

Detailed Description:

The investigators will enroll and scan 200 normal eyes of 100 healthy individuals using the Spectralis OCT. Each scan is graded on a scale of 0-40, with 0 representing the lowest quality and 40 the best possible one. Each of the subjects will be scanned numerous times using this noninvasive imaging tool, while trying to get as many scans as possible of different quality. The differences in the parameters between the scans will then be recoded.

Collected data will include age, sex, subjects' refractive status, visual acuity, full slit lamp exam and the participants' OCT characteristics and measurements.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Relation Between Macular and RNFL Thickness Measurement and Quality Grading in OCT
Study Start Date : March 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Arm Intervention/treatment
OCT exam
OCT exam No Arm No Intervention
Device: OCT exam
OCT exam




Primary Outcome Measures :
  1. correlation between quality grading and retinal and RNFL thickness [ Time Frame: up to 24 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: At least 20/30 visual acuity (BCVA), refractive error less than ±6 diopters (D) spherical equivalent or 3 D of astigmatism, and normal-appearing optic nerve head and retina on dilated fundus examination.

Exclusion Criteria:

  • Any history or evidence of eye disease or surgery.
  • Intraocular pressure (IOP) more than 22 mm Hg.
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Responsible Party: Ori Segal, M.D, Meir Medical Center
ClinicalTrials.gov Identifier: NCT02700750    
Other Study ID Numbers: 294-15
First Posted: March 7, 2016    Key Record Dates
Last Update Posted: March 7, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided