NCT04961398

Brief Summary

Evaluation of effect of various OCT scan speeds and filters on parameter measurements.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

June 21, 2021

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 14, 2021

Completed
Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

3 days

First QC Date

June 17, 2021

Last Update Submit

September 10, 2025

Conditions

Normal Eyes

Outcome Measures

Primary Outcomes (3)

  • Macular layer thicknesses

    ETDRS grid (9 sectors)

    during the intervention

  • Bruch's Membrane Opening (BMO)-Minimum Rim Width (MRW)

    Classification chart (6 sectors)

    during the intervention

  • Peripapillary Retinal Nerve Fiber Layer Thickness (RNFLT)

    Classification chart (6 sectors)

    during the intervention

Secondary Outcomes (1)

  • Adverse Events

    through study completion, an average of one day

Study Arms (3)

OCT speed 85 KHz

predicate speed

Device: OCT imaging

OCT speed 125 KHz

investigational speed

Device: OCT imaging

OCT speed 20 KHz

investigational speed

Device: OCT imaging

Interventions

OCT imagingDEVICE

OCT imaging on Normal Eyes without any filter and with various ND filters as per protocol

OCT speed 125 KHzOCT speed 20 KHzOCT speed 85 KHz

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adults with healthy eyes

You may qualify if:

  • Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
  • Age ≥ 22
  • Both eyes with an age-appropriate normal appearing OCT as determined by an investigator

You may not qualify if:

  • Subjects unable to read or write
  • Subjects with ocular media not sufficiently clear to obtain acceptable study-related imaging as determined by OCT imaging (without neutral optical density filter)
  • Subjects who cannot tolerate the imaging procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heidelberg Engineering, Inc.

Franklin, Massachusetts, 02038, United States

Location

Study Officials

  • Valerie M Leung, BOptom BS

    Heidelberg Engineering, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2021

First Posted

July 14, 2021

Study Start

June 21, 2021

Primary Completion

June 24, 2021

Study Completion

June 24, 2021

Last Updated

September 16, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)