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

Early Anesthesia vs Standard Anesthesia Clinical Trial

Official title:

A Comparison of Patient Perceptions Undergoing Manual Immediately Sequential Bilateral Cataract Surgery (M-ISBCS) vs Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery (ReLA-ISBCS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05480839
• Other study ID #: UptownEye2
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: August 31, 2022

Study information

• Verified date: July 2022
• 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Early Anesthesia vs Standard Anesthesia
• MCS vs ReLACS

Intervention

Procedure:
• M-IBCS
Manual Cataract Surgery - Phacoemulsification: removal of the eye lens and insertion of an intraocular lens implant
• ReLA-IBCS Early
Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery - ReLA-IBSCS with early administration of anesthesia
• ReLA-ISBCS
Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery - ReLA-IBSCS with standard administration of anesthesia

Locations

Country	Name	City	State
Canada	Uptown Eye Specialist	Brampton	Ontario

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 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	Effects of Early vs Standard administration of topical neurolept anesthesia on pain perception	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.	1 Year