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

Not Applicable

• Conditions: Early Anesthesia vs Standard Anesthesia; Immediately Sequential Bilateral Cataract Surgery; Pain Perception Postoperative; MCS vs ReLACS
• Interventions: Procedure: M-IBCS; Procedure: ReLA-IBCS Early; Procedure: ReLA-ISBCS

• Registration Number: NCT05480839
• Lead Sponsor: Uptown Eye Specialists

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Status Verified: 2022-07
• Study First Submitted: 2022-07-27
• Study First Submitted QC: 2022-07-27
• Last Update Submitted: 2022-07-27
• Study First Posted: 2022-07-29
• Last Update Posted: 2022-07-29
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual Immediately Sequential Bilateral Cataract Surgery (MCS)	M-IBCS	-
Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery (ReLA-ISBCS) Early	ReLA-IBCS Early	-
Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery (ReLA-ISBCS) Standard	ReLA-ISBCS	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Uptown Eye Specialist; 🇨🇦 Brampton, Ontario, Canada