To Analyze the Economics of Office-based (OBS) Versus Amb... | NCT07554391

Studies
To Analyze the Economics of Office-based (OBS) Versus Ambulatory Surgery Center (ASC)-Based Cataract Surgery.

NCT07554391

Sponsor

Rush Eye Associates

Status

Completed

Last Update Posted

Apr 28, 2026Actual

Enrollment

76Actual

Phase

Not provided

Conditions

Cataract

Interventions

Office based surgery

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

ID	Type	Description	Link
OBSvsASC	Registry Identifier	OBSvsASC

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2025Actual

Primary Completion Date

Aug 31, 2025Actual

Completion Date

Aug 31, 2025Actual

First Submitted Date

Apr 21, 2026

First Submission Date that Met QC Criteria

Apr 21, 2026

First Posted Date

Apr 28, 2026Actual

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

Apr 21, 2026

Last Update Posted Date

Apr 28, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

To analyze the economics of office-based (OBS) versus ambulatory surgery center (ASC)-based cataract surgery.

Detailed Description

This study was conducted as a randomized, controlled clinical trial at a single private practice institution. Patients presenting for routine cataract surgery scheduling were randomized prospectively to undergo the procedure in either the OBS or ASC-based setting. The primary outcome was total average cost for performing OBS versus ASC-based cataract surgery. The secondary outcome was total average facility reimbursement for OBS versus ASC-based cataract surgery.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

76Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Office based cataract surgery			Procedure: Office based surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Office based surgery	Procedure	Study subjects underwent office-based cataract surgery.	Office based cataract surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cost	Average cost for office based surgery	1 day
Average cost for office-based surgery	US dollars	Single surgical event

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Selected for routine cataract surgery

Exclusion Criteria:

Complex surgery
Certain systemic comorbidities
Limited mobility

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Visually significant cataract

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rush Eye		Amarillo	Texas	79109	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases