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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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MCS vs ReLACS, Pain Perception Postoperative, Early Anesthesia vs Standard Anesthesia, Immediately Sequential Bilateral Cataract Surgery

Intervention / Treatment
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* Procedure: M-IBCS
* Procedure: ReLA-IBCS Early
* Procedure: ReLA-ISBCS


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manual Immediately Sequential Bilateral Cataract Surgery (MCS)<br> | Procedure: M-IBCS<br>* Manual Cataract Surgery - Phacoemulsification: removal of the eye lens and insertion of an intraocular lens implant<br>|
| Experimental: Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery (ReLA-ISBCS) Early<br> | Procedure: ReLA-IBCS Early<br>* Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery - ReLA-IBSCS with early administration of anesthesia<br>|
| Experimental: Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery (ReLA-ISBCS) Standard<br> | Procedure: ReLA-ISBCS<br>* Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery - ReLA-IBSCS with standard administration of anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |