A Real-World Study of Interventional Clinical Outcomes in... | NCT07216677

Studies
A Real-World Study of Interventional Clinical Outcomes in Patients With Open Angle Glaucoma and Other Chronic Eye Diseases

NCT07216677

Sponsor

Interstat LLC

Status

Active, not recruiting

Last Update Posted

Oct 15, 2025Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Glaucoma
AMD
Diabetic Retinopathy (DR)

Interventions

Chronic Disease Intervention CDI

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

Oct 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 10, 2024Actual

Primary Completion Date

Oct 25, 2027Estimated

Completion Date

Oct 25, 2027Estimated

First Submitted Date

Oct 10, 2025

First Submission Date that Met QC Criteria

Oct 10, 2025

First Posted Date

Oct 14, 2025Actual

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

Oct 13, 2025

Last Update Posted Date

Oct 15, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a real world investigation of patient who have undergone treatments for chronic eye conditions such as glaucoma and AMD.

Detailed Description

The objective of the study is to understand the real-world outcomes after chronic disease treatments for glaucoma and AMD and to compare to reported clinical study outcomes

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

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Post-intervention Observational Group			Other: Chronic Disease Intervention CDI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chronic Disease Intervention CDI	Other	Intervention for the management of a chronic eye disease	Post-intervention Observational Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in Chronic Disease Interventional outcomes such as Intraocular pressure, best corrected vision and other parameters.	Longitudinal change in interventional chronic disease outcomes	up to 12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of Glaucoma or AMD or Diabetic Retinopathy Recent history of a chronic disease intervention in the prior 6 months

Exclusion Criteria:

Patient who are pregnant lactating younger than 18 years of age unable to execute informed consent.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with a chronic eye disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Interstat		White Plains	New York	10602	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma
D003930	Diabetic Retinopathy

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases
D012164	Retinal Diseases
D003925	Diabetic Angiopathies

Browse Leaves

Not provided

Browse Branches

Not provided