MCS vs ReLACSNCT05480839
Manual Immediately Sequential Bilateral Cataract Surgery (M-ISBCS) vs Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery (ReLA-ISBCS)
A study testing M-IBCS, ReLA-IBCS Early and ReLA-ISBCS in people with MCS vs ReLACS and Pain Perception Postoperative, run by Uptown Eye Specialists at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- MCS vs ReLACS, Pain Perception Postoperative, Early Anesthesia vs Standard Anesthesia
- What is being tested?
- M-IBCS, ReLA-IBCS Early and ReLA-ISBCS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2022to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Uptown Eye Specialist
Brampton, Ontario, L6Y0P6
Sohel Somani, MD, FRCSC, 4162920330, sohel@uptowneye.ca
About this study
Official title: A Comparison of Patient Perceptions Undergoing Manual Immediately Sequential Bilateral Cataract Surgery (M-ISBCS) vs Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery (ReLA-ISBCS)
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
- Being tested
- M-IBCS, ReLA-IBCS Early, ReLA-ISBCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M-IBCSProcedure or surgery
Manual Cataract Surgery - Phacoemulsification: removal of the eye lens and insertion of an intraocular lens implant
ReLA-IBCS EarlyProcedure or surgery
Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery - ReLA-IBSCS with early administration of anesthesia
ReLA-ISBCSProcedure or surgery
Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery - ReLA-IBSCS with standard administration of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Manual Immediately Sequential Bilateral Cataract Surgery (MCS) | Experimental | Not described Receives: Procedure: M-IBCS |
| Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery (ReLA-ISBCS) Early | Experimental | Not described Receives: Procedure: ReLA-IBCS Early |
| Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery (ReLA-ISBCS) Standard | Experimental | Not described Receives: Procedure: ReLA-ISBCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Perception between Manual Immediately Sequential Bilateral Cataract Surgery (M-ISBCS) and Refractive Laser-Assisted Immediately Sequential Cataract Surgery (ReLA-ISCS)
Pain perceptions of patients undergoing M-IBCS vs ReLA-ISBCS will be measured using the Numerical Rating Scale (NRS) with pain ratings from 0 to 10.
Measured: 1 year
Secondary outcomes (1)
Effects of Early vs Standard administration of topical neurolept anesthesia on pain perception
Pain perceptions of patients undergoing ReLA-ISBCS Early vs ReLA-ISBCS Standard will be measured using the Numerical Rating Scale (NRS) with pain ratings from 0 to 10.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start1 Jun 2022
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MCS vs ReLACSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uptown Eye Specialists
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480839
- Sponsor's protocol ID
- UptownEye2
- Status last verified
- Jul 2022
- First submitted
- 27 Jul 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Patient Perceptions Undergoing Manual Immediately Sequential Bilateral Cataract Surgery (M-ISBCS) vs Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery (ReLA-ISBCS)
- ClinicalTrials.gov ID
- NCT05480839
- Acronym / sponsor ID
- UptownEye2
- Conditions
- MCS vs ReLACS, Pain Perception Postoperative, Early Anesthesia vs Standard Anesthesia, Immediately Sequential Bilateral Cataract Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Uptown Eye SpecialistsUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Manual Immediately Sequential Bilateral Cataract Surgery (MCS) | Experimental | Procedure: M-IBCS |
| Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery (ReLA-ISBCS) Early | Experimental | Procedure: ReLA-IBCS Early |
| Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery (ReLA-ISBCS) Standard | Experimental | Procedure: ReLA-ISBCS |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M-IBCSManual Cataract Surgery - Phacoemulsification: removal of the eye lens and insertion of an intraocular lens implant | Procedure or surgery | Manual Immediately Sequential Bilateral Cataract Surgery (MCS) |
| ReLA-IBCS EarlyRefractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery - ReLA-IBSCS with early administration of anesthesia | Procedure or surgery | Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery (ReLA-ISBCS) Early |
| ReLA-ISBCSRefractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery - ReLA-IBSCS with standard administration of anesthesia | Procedure or surgery | Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery (ReLA-ISBCS) Standard |
Primary outcome
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
Pain perceptions of patients undergoing M-IBCS vs ReLA-ISBCS will be measured using the Numerical Rating Scale (NRS) with pain ratings from 0 to 10.
1 secondary outcome
Effects of Early vs Standard administration of topical neurolept anesthesia on pain perception
Time frame: 1 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing M-IBCS, ReLA-IBCS Early and ReLA-ISBCS in people with MCS vs ReLACS and Pain Perception Postoperative, run by Uptown Eye Specialists at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.