Manual Immediately Sequential Bilateral Cataract Surgery (M-ISBCS) vs Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery (ReLA-ISBCS)

Sponsor
Uptown Eye Specialists (Other)
Overall Status
Recruiting
CT.gov ID
NCT05480839
Collaborator
(none)
100
1
3
3
33.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: M-IBCS
  • Procedure: ReLA-IBCS Early
  • Procedure: ReLA-ISBCS
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Manual Immediately Sequential Bilateral Cataract Surgery (MCS)

Procedure: M-IBCS
Manual Cataract Surgery - Phacoemulsification: removal of the eye lens and insertion of an intraocular lens implant

Experimental: Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery (ReLA-ISBCS) Early

Procedure: ReLA-IBCS Early
Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery - ReLA-IBSCS with early administration of anesthesia

Experimental: Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery (ReLA-ISBCS) Standard

Procedure: ReLA-ISBCS
Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery - ReLA-IBSCS with standard administration of anesthesia

Outcome Measures

Primary Outcome Measures

  1. Pain Perception between Manual Immediately Sequential Bilateral Cataract Surgery (M-ISBCS) and Refractive Laser-Assisted Immediately Sequential Cataract Surgery (ReLA-ISCS) [1 year]

    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

  1. Effects of Early vs Standard administration of topical neurolept anesthesia on pain perception [1 Year]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Uptown Eye Specialist Brampton Ontario Canada L6Y0P6

Sponsors and Collaborators

  • Uptown Eye Specialists

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Uptown Eye Specialists
ClinicalTrials.gov Identifier:
NCT05480839
Other Study ID Numbers:
  • UptownEye2
First Posted:
Jul 29, 2022
Last Update Posted:
Jul 29, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 29, 2022