Recruiting

M-ISBCS vs. ReLA-ISBCS

Sponsor:

Uptown Eye Specialists

Code:

NCT05480839

Conditions

MCS vs ReLACS

Pain Perception Postoperative

Early Anesthesia vs Standard Anesthesia

Immediately Sequential Bilateral Cataract Surgery

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

M-IBCS

ReLA-IBCS Early

ReLA-ISBCS

Study Details

Brief summary:

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.

Conditions

MCS vs ReLACS

Pain Perception Postoperative

Early Anesthesia vs Standard Anesthesia

Immediately Sequential Bilateral Cataract Surgery

Study ID

NCT05480839

Start date

Jun 1, 2022

Status verified date

Jul, 2022

Completion date

Aug 31, 2022

Anticipated

Primary completion date

Aug 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Manual Immediately Sequential Bilateral Cataract Surgery (MCS)

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

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

Interventions

M-IBCS

Manual Cataract Surgery - Phacoemulsification: removal of the eye lens and insertion of an intraocular lens implant

ReLA-IBCS Early

Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery - ReLA-IBSCS with early administration of anesthesia

ReLA-ISBCS

Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery - ReLA-IBSCS with standard administration of anesthesia

Primary outcome measure

  • Pain Perception between Manual Immediately Sequential Bilateral Cataract Surgery (M-ISBCS) and Refractive Laser-Assisted Immediately Sequential Cataract Surgery (ReLA-ISCS) [ Time Frame: 1 year ]

Central Contacts and Locations

Locations

Uptown Eye Specialist

Recruiting

Brampton, Ontario, Canada, L6Y0P6

Contacts

Sohel Somani, MD, FRCSC

4162920330sohel@uptowneye.ca

More Information

Sponsor

Uptown Eye Specialists

Last update posted

Jul 29, 2022

Last verified

Jul, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Uptown Eye Specialists on 2022-07-29.