A Comparison of Patient Perceptions Undergoing Manual Cataract Surgery (MCS) vs Refractive Laser-assisted Cataract Surgery (ReLACS) in First and Second Eyes

NCT04623229 | Completed

• 1 other identifier: UptownEye
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

The focus of this study is to assess how pain can be mitigated for patients undergoing cataract surgery through the early application of anesthesia prior to the surgery as compared to the standard timing, and by using the ReLACS cataract surgery technique compared to the standard MCS technique.

Conditions

MCS vs ReLACS; Pain Perception Postoperatively First Eye vs Second Eye; Early Anesthesia vs Standard Anesthesia

Outcome Measures

Primary Outcomes (1)

• Pain Perception between Manual Cataract Surgery and Refractive Laser Assisted Cataract Surgery

  The pain scores will be measured using the Visual Analogue Scale (VAS) which is based on a 0 to 10 scale.

  1 year

Secondary Outcomes (2)

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

  1 year

• Differences in pain perception between first eye vs second eye

  1 year

Study Arms (3)

MCS

EXPERIMENTAL

Procedure: MCS

ReLACS Early

EXPERIMENTAL

Procedure: ReLACS Early

ReLACS Standard

EXPERIMENTAL

Procedure: ReLACS Standard

Interventions

MCS PROCEDURE

Manual Cataract Surgery

MCS

ReLACS Early PROCEDURE

ReLACS with early administration of anesthesia

ReLACS Early

ReLACS Standard PROCEDURE

ReLACS with standard time administration of anesthesia

ReLACS 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 (MCS or ReLACS)
• Patients who require surgery in both eyes by same surgeon
• Able to understand English and complete a pain assessment

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/medical marijuana

Sponsors & Collaborators

• Uptown Eye Specialists: lead

Study Sites (1)

Uptown Eye Speicialists

Brampton, Otario, L6Y0P6, Canada

Location

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 9, 2020
• First Posted: November 10, 2020
• Study Start: July 1, 2019
• Primary Completion: September 15, 2020
• Study Completion: September 15, 2020
• Last Updated: November 10, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)