Screening Protocol | NCT06135727

Studies
Screening Protocol

NCT06135727

Sponsor

Topcon Corporation

Status

Terminated

Last Update Posted

Sep 10, 2025Actual

Enrollment

26Actual

Phase

Not provided

Conditions

Glaucoma

Interventions

Maestro2 OCT

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

limited access to study population

Expanded Access Info

Start Date

Nov 7, 2023Actual

Primary Completion Date

Aug 2, 2024Actual

Completion Date

Aug 2, 2024Actual

First Submitted Date

Nov 13, 2023

First Submission Date that Met QC Criteria

Nov 13, 2023

First Posted Date

Nov 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2025

Last Update Posted Date

Sep 10, 2025Actual

Description Module

Brief Summary

The objective of this study is to collect data for the development and validation a screening process using aggregate data.

In this study, data collection will encompass both retrospective and prospective approaches across multiple sites in the United States.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Label	Type	Description	Intervention Names
Pathology (glaucoma) arm			Device: Maestro2 OCT
Normal arm			Device: Maestro2 OCT

Name	Type	Description	Arm Group Labels	Other Names
Maestro2 OCT	Device	3D Wide (12mmx9mm) OCT scan using the Maestro (Topcon, Japan)	Normal arm Pathology (glaucoma) arm

Measure	Description	Time Frame
RNFL and GCL thickness	Using Maestro2 OCT	1 day

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects 22 years of age or older on the date of data collection (retrospective) or informed consent (prospective).
For prospective data collection or missing retrospective data collection, subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent.
BCVA 20/40 or better (each eye).
Normal eyes to have normal ocular examination in both eyes
Normal eyes to have IOP ≤ 21 mmHg in both eyes
Pathology eyes to have clinical diagnosis of mild or moderate glaucoma in at least one eye

Exclusion Criteria:

For prospective or missing retrospective data collection, subjects unable to tolerate ophthalmic testing.
Concomitant diseases known to affect the visual field: history of leukemia, dementia, Parkinson's disease, Alzheimer's disease, stroke, or autoimmune diseases.
History of intraocular surgery (uncomplicated cataract or glaucoma surgeries are accepted)
Ocular findings or history of co-morbidities, including, but not limited to: uveitis, non-glaucomatous optic neuropathy, trauma, retinal detachment, vein or artery occlusions, wet age-related macular degeneration, geographic atrophy, proliferative diabetic retinopathy, vitreous hemorrhage, severe cataract, severe non-proliferative diabetic retinopathy. Controlled diabetes and hypertension participants can be included.
Unreliable VF testing and/or poor-quality OCT scans.
Poor fixation.
Pathology eyes with severe glaucoma
Pathology eyes with glaucoma suspect diagnosis
Pathology eyes with Ocular Hypertensive diagnosis

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects with normal eyes and eyes with moderate or severe glaucoma

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Mary Durbin, PhD	Topcon Corporation	Study Chair
Nevin W. El-Nimri, OD, PhD	Topcon Corporation	Principal Investigator

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases