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

Uptown Eye Specialists100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

MCS vs ReLACS Pain Perception Postoperative Early Anesthesia vs Standard Anesthesia

Interventions

M-IBCSPROCEDURE

Manual Cataract Surgery - Phacoemulsification: removal of the eye lens and insertion of an intraocular lens implant

ReLA-IBCS EarlyPROCEDURE

Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery - ReLA-IBSCS with early administration of anesthesia

ReLA-ISBCSPROCEDURE

Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery - ReLA-IBSCS with standard administration of anesthesia

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 1 year

Secondary Outcomes

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.

Time frame: 1 Year