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

Nerve Fiber Bundle Defect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02700750
• Other study ID #: 294-15
• Status: Not yet recruiting
• Phase: N/A
• First received: February 21, 2016
• Last updated: March 1, 2016
• Start date: March 2016
• Est. completion date: March 2017

Study information

• Verified date: March 2016
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Nerve Fiber Bundle Defect
• Retinal Diseases

Intervention

Device:
• OCT exam
OCT exam

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation between quality grading and retinal and RNFL thickness		up to 24 months	No