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

Not Applicable

Completed

• Conditions: Pain Perception Postoperatively First Eye vs Second Eye; MCS vs ReLACS; Early Anesthesia vs Standard Anesthesia
• Interventions: Procedure: MCS; Procedure: ReLACS Early; Procedure: ReLACS Standard

• Registration Number: NCT04623229
• Lead Sponsor: Uptown Eye Specialists

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2020-07-09
• Primary Completion: 2020-09-15
• Study Completion: 2020-09-15
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-04
• Last Update Submitted: 2020-11-04
• Study First Posted: 2020-11-10
• Last Update Posted: 2020-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

1. Patients undergoing uncomplicated cataract surgery with either surgical technique (MCS or ReLACS)
2. Patients who require surgery in both eyes by same surgeon
3. Able to understand English and complete a pain assessment

Exclusion Criteria

1. 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
2. Pre-existing chronic eye pain or uveitis, or complicated cataracts (dislocation, zonulopathy)
3. Pre-existing uncontrolled glaucoma/high IOP
4. Intraoperative complications or non-routine cataracts (eg. Sutures, excessive time of surgery)
5. Any patient who requires Deep Sedation (Propofol), GA or preOP Ativan
6. Patients under 40, severe obesity (BMI >35)
7. Chronic pain/narcotics/Recreational/medical marijuana

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MCS	MCS	-
ReLACS Early	ReLACS Early	-
ReLACS Standard	ReLACS Standard	-

Primary Outcome Measures

Name	Time	Method
Pain Perception between Manual Cataract Surgery and Refractive Laser Assisted Cataract Surgery	1 year	The pain scores will be measured using the Visual Analogue Scale (VAS) which is based on a 0 to 10 scale.

Secondary Outcome Measures

Name	Time	Method
Differences in pain perception between first eye vs second eye	1 year	The pain scores will be measured using the Visual Analogue Scale (VAS) which is based on a 0 to 10 scale.
Effects of Early vs Standard administration of neurolept anesthesia on pain perception	1 year	The pain scores will be measured using the Visual Analogue Scale (VAS) which is based on a 0 to 10 scale.

Trial Locations

Locations (1)

Uptown Eye Speicialists; 🇨🇦 Brampton, Otario, Canada