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Clinical Trials/NCT05480839
NCT05480839
Unknown
Not Applicable

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)

Uptown Eye Specialists1 site in 1 country100 target enrollmentJune 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
MCS vs ReLACS
Sponsor
Uptown Eye Specialists
Enrollment
100
Locations
1
Primary Endpoint
Pain Perception between Manual Immediately Sequential Bilateral Cataract Surgery (M-ISBCS) and Refractive Laser-Assisted Immediately Sequential Cataract Surgery (ReLA-ISCS)
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2022
End Date
August 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

  • Effects of Early vs Standard administration of topical neurolept anesthesia on pain perception(1 Year)

Study Sites (1)

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