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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04623229
Recruitment Status : Completed
First Posted : November 10, 2020
Last Update Posted : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
Uptown Eye Specialists

Study Description
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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.

Condition or disease Intervention/treatment Phase
MCS vs ReLACS Pain Perception Postoperatively First Eye vs Second Eye Early Anesthesia vs Standard Anesthesia Procedure: MCS Procedure: ReLACS Early Procedure: ReLACS Standard Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Comparison of Patient Perceptions Undergoing Manual Cataract Surgery (MCS) vs Refractive Laser-assisted Cataract Surgery (ReLACS) in First and Second Eyes
Actual Study Start Date : July 1, 2019
Actual Primary Completion Date : September 15, 2020
Actual Study Completion Date : September 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04623229


Locations
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Canada, Otario
Uptown Eye Speicialists
Brampton, Otario, Canada, L6Y0P6
Sponsors and Collaborators
Uptown Eye Specialists
More Information
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Responsible Party: Uptown Eye Specialists
ClinicalTrials.gov Identifier: NCT04623229    
Other Study ID Numbers: UptownEye
First Posted: November 10, 2020    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases