Early Anesthesia vs Standard Anesthesia, Immediately Sequential Bilateral Cataract Surgery, MCS vs ReLACS, Pain Perception Postoperative
Conditions
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.
Interventions
PROCEDUREM-IBCS
Manual Cataract Surgery - Phacoemulsification: removal of the eye lens and insertion of an intraocular lens implant
PROCEDUREReLA-IBCS Early
Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery - ReLA-IBSCS with early administration of anesthesia
PROCEDUREReLA-ISBCS
Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery - ReLA-IBSCS with standard administration of anesthesia
Sponsors
Uptown Eye Specialists
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Perception between Manual Immediately Sequential Bilateral Cataract Surgery (M-ISBCS) and Refractive Laser-Assisted Immediately Sequential Cataract Surgery (ReLA-ISCS) | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effects of Early vs Standard administration of topical neurolept anesthesia on pain perception | 1 Year | 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. |
Countries
Canada
Outcome results
None listed