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CompletedNCT04623229Updated Nov 10, 2020

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

An interventional study of MCS and ReLACS Early in MCS vs ReLACS, Pain Perception Postoperatively First Eye vs Second Eye and Early Anesthesia vs Standard Anesthesia, sponsored by Uptown Eye Specialists. Completed at 1 site in Canada. Per ClinicalTrials.gov, last updated 2020-11-10.

Sponsored by Uptown Eye Specialists · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jul 2019, registered Jul 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
103
Allocation
Randomized
Sex
All
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Study 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.

02

Conditions studied

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

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03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 103 is above the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Uptown Eye Specialists is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
103 participants (actual)

Study arms

  • Experimental
    MCS

    Procedure: MCS

  • Experimental
    ReLACS Early

    Procedure: ReLACS Early

  • Experimental
    ReLACS Standard

    Procedure: ReLACS Standard

Interventions

  • ProcedureMCS

    Manual Cataract Surgery

  • ProcedureReLACS Early

    ReLACS with early administration of anesthesia

  • ProcedureReLACS Standard

    ReLACS with standard time administration of anesthesia

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What researchers measure

Primary outcomes

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

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

    Time frame: 1 year

Secondary outcomes

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

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

    Time frame: 1 year

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

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

    Time frame: 1 year

07

Study locations

1 site
  • Uptown Eye Speicialists
    Brampton, Otario L6Y0P6, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04623229
Lead sponsor
Uptown Eye Specialists
Responsible party
Sponsor
First posted
Nov 10, 2020
Start date
Jul 1, 2019
Primary completion
Sep 15, 2020
Completion
Sep 15, 2020
Last update
Nov 10, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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