A Comparison of Patient Perceptions Undergoing Manual Cat... | NCT04623229

Studies
A Comparison of Patient Perceptions Undergoing Manual Cataract Surgery (MCS) vs Refractive Laser-assisted Cataract Surgery (ReLACS) in First and Second Eyes

NCT04623229

Sponsor

Uptown Eye Specialists

Status

Completed

Last Update Posted

Nov 10, 2020Actual

Enrollment

103Actual

Phase

Not Applicable

Conditions

MCS vs ReLACS
Pain Perception Postoperatively First Eye vs Second Eye
Early Anesthesia vs Standard Anesthesia

Interventions

MCS
ReLACS Early
ReLACS Standard

Countries

Canada

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

Status Module

Record Verification Date

Nov 2020

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

Jul 1, 2019Actual

Primary Completion Date

Sep 15, 2020Actual

Completion Date

Sep 15, 2020Actual

First Submitted Date

Jul 9, 2020

First Submission Date that Met QC Criteria

Nov 4, 2020

First Posted Date

Nov 10, 2020Actual

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

Nov 4, 2020

Last Update Posted Date

Nov 10, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

The focus of this study is to assess how pain can be mitigated for patients undergoing cataract surgery through the early application of anesthesia prior to the surgery as compared to the standard timing, and by using the ReLACS cataract surgery technique compared to the standard MCS technique.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

103Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
MCS	Experimental	Procedure: MCS
ReLACS Early	Experimental	Procedure: ReLACS Early
ReLACS Standard	Experimental	Procedure: ReLACS Standard

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MCS	Procedure	Manual Cataract Surgery	MCS
ReLACS Early

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain Perception between Manual Cataract Surgery and Refractive Laser Assisted Cataract Surgery	The pain scores will be measured using the Visual Analogue Scale (VAS) which is based on a 0 to 10 scale.	1 year

Secondary Outcomes

Measure	Description	Time Frame
Effects of Early vs Standard administration of neurolept anesthesia on pain perception	The pain scores will be measured using the Visual Analogue Scale (VAS) which is based on a 0 to 10 scale.	1 year
Differences in pain perception between first eye vs second eye

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing uncomplicated cataract surgery with either surgical technique (MCS or ReLACS)
Patients who require surgery in both eyes by same surgeon
Able to understand English and complete a pain assessment

Exclusion Criteria:

Deafness or communication disorder, known Dementia, Severe COPD/Asthma (severe lung disorder), Severe OSA, Psychiatric or Anxiety conditions, involuntary movement disorders, allergy to the anesthesia, any conditions requiring intraoperative iris manipulation, any prior ocular surgery
Pre-existing chronic eye pain or uveitis, or complicated cataracts (dislocation, zonulopathy)
Pre-existing uncontrolled glaucoma/high IOP
Intraoperative complications or non-routine cataracts (eg. Sutures, excessive time of surgery)
Any patient who requires Deep Sedation (Propofol), GA or preOP Ativan
Patients under 40, severe obesity (BMI >35)
Chronic pain/narcotics/Recreational/medical marijuana

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Uptown Eye Speicialists		Brampton	Otario	L6Y0P6	Canada

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

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.