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

Early Anesthesia vs Standard Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04623229
• Other study ID #: UptownEye
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: September 15, 2020

Study information

• Verified date: November 2020
• Source: Uptown Eye Specialists
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: September 15, 2020
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• MCS
Manual Cataract Surgery
• ReLACS Early
ReLACS with early administration of anesthesia
• ReLACS Standard
ReLACS with standard time administration of anesthesia

Locations

Country	Name	City	State
Canada	Uptown Eye Speicialists	Brampton	Otario

Sponsors (1)

Lead Sponsor	Collaborator
Uptown Eye Specialists

Country where clinical trial is conducted

Canada, 

Outcome

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