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OpenTrials
Completed

NCT Number: NCT04623229

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uptown Eye Speicialists

Brampton, Otario, L6Y0P6, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MCS

Procedure

Manual Cataract Surgery

ReLACS Early

Procedure

ReLACS with early administration of anesthesia

ReLACS Standard

Procedure

ReLACS with standard time administration of anesthesia

Primary outcomes

  1. Pain Perception between Manual Cataract Surgery and Refractive Laser Assisted Cataract Surgery

    Time frame: 1 year

    The pain scores will be measured using the Visual Analogue Scale (VAS) which is based on a 0 to 10 scale.

Secondary outcomes

  1. Effects of Early vs Standard administration of neurolept anesthesia on pain perception

    Time frame: 1 year

    The pain scores will be measured using the Visual Analogue Scale (VAS) which is based on a 0 to 10 scale.

  2. Differences in pain perception between first eye vs second eye

    Time frame: 1 year

    The pain scores will be measured using the Visual Analogue Scale (VAS) which is based on a 0 to 10 scale.

Sponsors and collaborators

Lead sponsor

Uptown Eye Specialists

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 10, 2020
Registry last updated
Nov 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.