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

NCT05480839 | Unknown

• 1 other identifier: UptownEye2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

MCS vs ReLACS; Pain Perception Postoperative; Early Anesthesia vs Standard Anesthesia; Immediately Sequential Bilateral Cataract Surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (1)

• Effects of Early vs Standard administration of topical neurolept anesthesia on pain perception

  1 Year

Study Arms (3)

Manual Immediately Sequential Bilateral Cataract Surgery (MCS)

EXPERIMENTAL

Procedure: M-IBCS

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

EXPERIMENTAL

Procedure: ReLA-IBCS Early

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

EXPERIMENTAL

Procedure: ReLA-ISBCS

Interventions

M-IBCS PROCEDURE

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

Manual Immediately Sequential Bilateral Cataract Surgery (MCS)

ReLA-IBCS Early PROCEDURE

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

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

ReLA-ISBCS PROCEDURE

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

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Uptown Eye Specialists: lead

Study Sites (1)

Uptown Eye Specialist

Brampton, Ontario, L6Y0P6, Canada

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: July 29, 2022
• Study Start: June 1, 2022
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)