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

Uptown Eye Specialists

Status: Enrolling

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

Treatments: Procedure: ReLA-ISBCS; Procedure: M-IBCS; Procedure: ReLA-IBCS Early

Study type: Interventional

Funder types: Other

Identifiers

NCT05480839

UptownEye2

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 3 patient groups

Manual Immediately Sequential Bilateral Cataract Surgery (MCS)

Experimental group

Treatment:

Procedure: M-IBCS

Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery (ReLA-ISBCS) Early

Experimental group

Treatment:

Procedure: ReLA-IBCS Early

Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery (ReLA-ISBCS) Standard

Experimental group

Treatment:

Procedure: ReLA-ISBCS