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Manual Immediately Sequential Bilateral Cataract Surgery (M-ISBCS) vs Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery (ReLA-ISBCS)

NCT ID: NCT05480839

Last Updated: 2022-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2022-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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MCS vs ReLACS Pain Perception Postoperative Early Anesthesia vs Standard Anesthesia Immediately Sequential Bilateral Cataract Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Manual Immediately Sequential Bilateral Cataract Surgery (MCS)

Group Type EXPERIMENTAL

M-IBCS

Intervention Type PROCEDURE

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

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

Group Type EXPERIMENTAL

ReLA-IBCS Early

Intervention Type PROCEDURE

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

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

Group Type EXPERIMENTAL

ReLA-ISBCS

Intervention Type PROCEDURE

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

Interventions

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M-IBCS

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

Intervention Type PROCEDURE

ReLA-IBCS Early

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

Intervention Type PROCEDURE

ReLA-ISBCS

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Uptown Eye Specialists

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Uptown Eye Specialist

Brampton, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Facility Contacts

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Sohel Somani, MD, FRCSC

Role: primary

Other Identifiers

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UptownEye2

Identifier Type: -

Identifier Source: org_study_id