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

NCT ID: NCT04623229

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-09-15

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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MCS

Group Type EXPERIMENTAL

MCS

Intervention Type PROCEDURE

Manual Cataract Surgery

ReLACS Early

Group Type EXPERIMENTAL

ReLACS Early

Intervention Type PROCEDURE

ReLACS with early administration of anesthesia

ReLACS Standard

Group Type EXPERIMENTAL

ReLACS Standard

Intervention Type PROCEDURE

ReLACS with standard time administration of anesthesia

Interventions

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MCS

Manual Cataract Surgery

Intervention Type PROCEDURE

ReLACS Early

ReLACS with early administration of anesthesia

Intervention Type PROCEDURE

ReLACS Standard

ReLACS with standard time administration of anesthesia

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. 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
2. Pre-existing chronic eye pain or uveitis, or complicated cataracts (dislocation, zonulopathy)
3. Pre-existing uncontrolled glaucoma/high IOP
4. Intraoperative complications or non-routine cataracts (eg. Sutures, excessive time of surgery)
5. Any patient who requires Deep Sedation (Propofol), GA or preOP Ativan
6. Patients under 40, severe obesity (BMI \>35)
7. Chronic pain/narcotics/Recreational/medical marijuana
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Uptown Eye Specialists

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Uptown Eye Speicialists

Brampton, Otario, Canada

Site Status

Countries

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Canada

Other Identifiers

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UptownEye

Identifier Type: -

Identifier Source: org_study_id