Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04623229
Enrollment
103
Registered
2020-11-10
Start date
2019-07-01
Completion date
2020-09-15
Last updated
2020-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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.

Interventions

PROCEDUREMCS

Manual Cataract Surgery

PROCEDUREReLACS Early

ReLACS with early administration of anesthesia

PROCEDUREReLACS Standard

ReLACS with standard time administration of anesthesia

Sponsors

Uptown Eye Specialists
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pain Perception between Manual Cataract Surgery and Refractive Laser Assisted Cataract Surgery1 yearThe pain scores will be measured using the Visual Analogue Scale (VAS) which is based on a 0 to 10 scale.

Secondary

MeasureTime frameDescription
Effects of Early vs Standard administration of neurolept anesthesia on pain perception1 yearThe pain scores will be measured using the Visual Analogue Scale (VAS) which is based on a 0 to 10 scale.
Differences in pain perception between first eye vs second eye1 yearThe pain scores will be measured using the Visual Analogue Scale (VAS) which is based on a 0 to 10 scale.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026