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

November 4, 2020 updated by: Uptown Eye Specialists
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Otario
      • Brampton, Otario, Canada, L6Y0P6
        • Uptown Eye Speicialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: MCS
Procedure: MCS
Manual Cataract Surgery
EXPERIMENTAL: ReLACS Early
Procedure: ReLACS Early
ReLACS with early administration of anesthesia
EXPERIMENTAL: ReLACS Standard
Procedure: ReLACS Standard
ReLACS with standard time administration of anesthesia

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uptown Eye Specialists

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2019

Primary Completion (ACTUAL)

September 15, 2020

Study Completion (ACTUAL)

September 15, 2020

Study Registration Dates

First Submitted

July 9, 2020

First Submitted That Met QC Criteria

November 4, 2020

First Posted (ACTUAL)

November 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UptownEye

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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