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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

U

Uptown Eye Specialists

Status

Completed

Conditions

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

Treatments

Procedure: ReLACS Early
Procedure: ReLACS Standard
Procedure: MCS

Study type

Interventional

Funder types

Other

Identifiers

NCT04623229
UptownEye

Details and patient eligibility

About

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.

Enrollment

103 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Patients undergoing uncomplicated cataract surgery with either surgical technique (MCS or ReLACS)
  2. Patients who require surgery in both eyes by same surgeon
  3. Able to understand English and complete a pain assessment

Exclusion criteria

  1. 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
  2. Pre-existing chronic eye pain or uveitis, or complicated cataracts (dislocation, zonulopathy)
  3. Pre-existing uncontrolled glaucoma/high IOP
  4. Intraoperative complications or non-routine cataracts (eg. Sutures, excessive time of surgery)
  5. Any patient who requires Deep Sedation (Propofol), GA or preOP Ativan
  6. Patients under 40, severe obesity (BMI >35)
  7. Chronic pain/narcotics/Recreational/medical marijuana

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

103 participants in 3 patient groups

MCS
Experimental group
Treatment:
Procedure: MCS
ReLACS Early
Experimental group
Treatment:
Procedure: ReLACS Early
ReLACS Standard
Experimental group
Treatment:
Procedure: ReLACS Standard

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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