Back to resultsManual Immediately Sequential Bilateral Cataract Surgery (M-ISBCS) vs Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery (ReLA-ISBCS)
Primary Purpose
MCS vs ReLACS, Pain Perception Postoperative, Early Anesthesia vs Standard Anesthesia
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
M-IBCS
ReLA-IBCS Early
ReLA-ISBCS
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 (M-ISBCS or ReLA-ISBCS)
- Patients who require surgery in both eyes by the same surgeon
- Able to understand English and complete a pain assessment (NRS)
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 or medical marijuana
Sites / Locations
- Uptown Eye SpecialistRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Manual Immediately Sequential Bilateral Cataract Surgery (MCS)
Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery (ReLA-ISBCS) Early
Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery (ReLA-ISBCS) Standard
Arm Description
Outcomes
Primary Outcome Measures
Pain Perception between Manual Immediately Sequential Bilateral Cataract Surgery (M-ISBCS) and Refractive Laser-Assisted Immediately Sequential Cataract Surgery (ReLA-ISCS)
Pain perceptions of patients undergoing M-IBCS vs ReLA-ISBCS will be measured using the Numerical Rating Scale (NRS) with pain ratings from 0 to 10.
Secondary Outcome Measures
Effects of Early vs Standard administration of topical neurolept anesthesia on pain perception
Pain perceptions of patients undergoing ReLA-ISBCS Early vs ReLA-ISBCS Standard will be measured using the Numerical Rating Scale (NRS) with pain ratings from 0 to 10.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05480839
Brief Title
Manual Immediately Sequential Bilateral Cataract Surgery (M-ISBCS) vs Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery (ReLA-ISBCS)
Official Title
A Comparison of Patient Perceptions Undergoing Manual Immediately Sequential Bilateral Cataract Surgery (M-ISBCS) vs Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery (ReLA-ISBCS)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)
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 the differences in patient perceptions of pain undergoing cataract surgery by using the Refractive Laser-Assisted Cataract Surgery (ReLACS) technique compared to the standard Manual Cataract Surgery (MCS) technique using an immediately sequential bilateral approach. This study also aims to further explore difference in patients' perceptions of pain depending on timing of neurolept anesthesia in the ReLACS technique. The importance of this study is appreciated patient perception of pain during ReLACS, which is an emerging technique for cataract surgery and has been sparsely reported on to date. This investigation will include the analysis of various surgical, ocular, medical, and psychosocial metrics of patients undergoing both ReLACS and MCS at Uptown Eye specialist.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MCS vs ReLACS, Pain Perception Postoperative, Early Anesthesia vs Standard Anesthesia, Immediately Sequential Bilateral Cataract Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Manual Immediately Sequential Bilateral Cataract Surgery (MCS)
Arm Type
Experimental
Arm Title
Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery (ReLA-ISBCS) Early
Arm Type
Experimental
Arm Title
Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery (ReLA-ISBCS) Standard
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
M-IBCS
Intervention Description
Manual Cataract Surgery - Phacoemulsification: removal of the eye lens and insertion of an intraocular lens implant
Intervention Type
Procedure
Intervention Name(s)
ReLA-IBCS Early
Intervention Description
Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery - ReLA-IBSCS with early administration of anesthesia
Intervention Type
Procedure
Intervention Name(s)
ReLA-ISBCS
Intervention Description
Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery - ReLA-IBSCS with standard administration of anesthesia
Primary Outcome Measure Information:
Title
Pain Perception between Manual Immediately Sequential Bilateral Cataract Surgery (M-ISBCS) and Refractive Laser-Assisted Immediately Sequential Cataract Surgery (ReLA-ISCS)
Description
Pain perceptions of patients undergoing M-IBCS vs ReLA-ISBCS will be measured using the Numerical Rating Scale (NRS) with pain ratings from 0 to 10.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Effects of Early vs Standard administration of topical neurolept anesthesia on pain perception
Description
Pain perceptions of patients undergoing ReLA-ISBCS Early vs ReLA-ISBCS Standard will be measured using the Numerical Rating Scale (NRS) with pain ratings from 0 to 10.
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 (M-ISBCS or ReLA-ISBCS)
Patients who require surgery in both eyes by the same surgeon
Able to understand English and complete a pain assessment (NRS)
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 or medical marijuana
Facility Information:
Facility Name
Uptown Eye Specialist
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6Y0P6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sohel Somani, MD, FRCSC
Phone
4162920330
Email
sohel@uptowneye.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Manual Immediately Sequential Bilateral Cataract Surgery (M-ISBCS) vs Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery (ReLA-ISBCS)
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