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

Study Overview
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Brief Summary
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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.

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

Conditions
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MCS vs ReLACS, Pain Perception Postoperatively First Eye vs Second Eye, Early Anesthesia vs Standard Anesthesia

Intervention / Treatment
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* Procedure: MCS
* Procedure: ReLACS Early
* Procedure: ReLACS Standard


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing uncomplicated cataract surgery with either surgical technique (MCS or ReLACS) Patients who require surgery in both eyes by same surgeon Able to understand English and complete a pain assessment 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/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: MCS<br> | Procedure: MCS<br>* Manual Cataract Surgery<br>|
| Experimental: ReLACS Early<br> | Procedure: ReLACS Early<br>* ReLACS with early administration of anesthesia<br>|
| Experimental: ReLACS Standard<br> | Procedure: ReLACS Standard<br>* ReLACS with standard time 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 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 Outcome Measures

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