MCS vs ReLACSNCT04623229
A Comparison of Patient Perceptions Undergoing Manual Cataract Surgery (MCS) vs Refractive Laser-assisted Cataract Surgery (ReLACS) in First and Second Eyes
A study testing MCS, ReLACS Early and ReLACS Standard in people with MCS vs ReLACS and Pain Perception Postoperatively First Eye vs Second Eye, run by Uptown Eye Specialists at 1 site in Canada.
Trial 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. 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 Postoperatively First Eye vs Second Eye, Early Anesthesia vs Standard Anesthesia
- What is being tested?
- MCS, ReLACS Early and ReLACS Standard
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2019to 15 Sep 2020
- 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 (MCS or ReLACS)
- Patients who require surgery in both eyes by same surgeon
- Able to understand English and complete a pain assessment
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/medical marijuana
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- MCS vs ReLACS, Pain Perception Postoperatively First Eye vs Second Eye, Early Anesthesia vs Standard Anesthesia
- Being tested
- MCS, ReLACS Early, ReLACS Standard
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCSProcedure or surgery
Manual Cataract Surgery
ReLACS EarlyProcedure or surgery
ReLACS with early administration of anesthesia
ReLACS StandardProcedure or surgery
ReLACS with standard time administration of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| MCS | Experimental | Not described Receives: Procedure: MCS |
| ReLACS Early | Experimental | Not described Receives: Procedure: ReLACS Early |
| ReLACS Standard | Experimental | Not described Receives: Procedure: ReLACS Standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (2)
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.
Measured: 1 year
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.
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 posted10 Nov 2020
- Study start1 Jul 2019
- Primary completion15 Sep 2020
- Study completion15 Sep 2020
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
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uptown Eye Specialists
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623229
- Sponsor's protocol ID
- UptownEye
- Status last verified
- Nov 2020
- First submitted
- 9 Jul 2020
- Last updated
- 10 Nov 2020
- 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 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Patient Perceptions Undergoing Manual Cataract Surgery (MCS) vs Refractive Laser-assisted Cataract Surgery (ReLACS) in First and Second Eyes
- ClinicalTrials.gov ID
- NCT04623229
- Acronym / sponsor ID
- UptownEye
- Conditions
- MCS vs ReLACS, Pain Perception Postoperatively First Eye vs Second Eye, Early Anesthesia vs Standard Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Uptown Eye SpecialistsUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 10 Nov 2020 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MCS | Experimental | Procedure: MCS |
| ReLACS Early | Experimental | Procedure: ReLACS Early |
| ReLACS Standard | Experimental | Procedure: ReLACS Standard |
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 (MCS or ReLACS)
- Patients who require surgery in both eyes by same surgeon
- Able to understand English and complete a pain assessment
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 |
|---|---|---|
| MCSManual Cataract Surgery | Procedure or surgery | MCS |
| ReLACS EarlyReLACS with early administration of anesthesia | Procedure or surgery | ReLACS Early |
| ReLACS StandardReLACS with standard time administration of anesthesia | Procedure or surgery | ReLACS Standard |
Primary outcome
Pain Perception between Manual Cataract Surgery and Refractive Laser Assisted Cataract Surgery
Time frame: 1 year
The pain scores will be measured using the Visual Analogue Scale (VAS) which is based on a 0 to 10 scale.
2 secondary outcomes
Effects of Early vs Standard administration of neurolept anesthesia on pain perception
Time frame: 1 year
Differences in pain perception between first eye vs second eye
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MCS, ReLACS Early and ReLACS Standard in people with MCS vs ReLACS and Pain Perception Postoperatively First Eye vs Second Eye, 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: finished, as of the sponsor's last update on 10 Nov 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Perception between Manual Cataract Surgery and Refractive Laser Assisted Cataract Surgery (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 10 Nov 2020.