Back to resultsA Comparison of Patient Perceptions Undergoing Manual Cataract Surgery (MCS) vs Refractive Laser-assisted Cataract Surgery (ReLACS) in First and Second Eyes
Primary Purpose
MCS vs ReLACS, Pain Perception Postoperatively First Eye vs Second Eye, Early Anesthesia vs Standard Anesthesia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MCS
ReLACS Early
ReLACS Standard
Sponsored by
About this trial
This is an interventional treatment trial for MCS vs ReLACS
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
Sites / Locations
- Uptown Eye Speicialists
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
MCS
ReLACS Early
ReLACS Standard
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Differences in pain perception between first eye vs second eye
The pain scores will be measured using the Visual Analogue Scale (VAS) which is based on a 0 to 10 scale.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04623229
Brief Title
A Comparison of Patient Perceptions Undergoing Manual Cataract Surgery (MCS) vs Refractive Laser-assisted Cataract Surgery (ReLACS) in First and Second Eyes
Official Title
A Comparison of Patient Perceptions Undergoing Manual Cataract Surgery (MCS) vs Refractive Laser-assisted Cataract Surgery (ReLACS) in First and Second Eyes
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
September 15, 2020 (Actual)
Study Completion Date
September 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uptown Eye Specialists
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MCS vs ReLACS, Pain Perception Postoperatively First Eye vs Second Eye, Early Anesthesia vs Standard Anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MCS
Arm Type
Experimental
Arm Title
ReLACS Early
Arm Type
Experimental
Arm Title
ReLACS Standard
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
MCS
Intervention Description
Manual Cataract Surgery
Intervention Type
Procedure
Intervention Name(s)
ReLACS Early
Intervention Description
ReLACS with early administration of anesthesia
Intervention Type
Procedure
Intervention Name(s)
ReLACS Standard
Intervention Description
ReLACS with standard time administration of anesthesia
Primary Outcome Measure Information:
Title
Pain Perception between Manual Cataract Surgery and Refractive Laser Assisted Cataract Surgery
Description
The pain scores will be measured using the Visual Analogue Scale (VAS) which is based on a 0 to 10 scale.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Effects of Early vs Standard administration of neurolept anesthesia on pain perception
Description
The pain scores will be measured using the Visual Analogue Scale (VAS) which is based on a 0 to 10 scale.
Time Frame
1 year
Title
Differences in pain perception between first eye vs second eye
Description
The pain scores will be measured using the Visual Analogue Scale (VAS) which is based on a 0 to 10 scale.
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Uptown Eye Speicialists
City
Brampton
State/Province
Otario
ZIP/Postal Code
L6Y0P6
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Comparison of Patient Perceptions Undergoing Manual Cataract Surgery (MCS) vs Refractive Laser-assisted Cataract Surgery (ReLACS) in First and Second Eyes
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