CataractCATALYSNCT03097562
Wound Architecture and Functional Outcome After Cataract Surgery With Manual vs.Femtosecond Laser Assisted Procedures
A study testing Femtosecond cataract surgery in people with Cataract, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial summary
This study is the long term analysis of two types of FSL 3-plane corneal wound profiles, namely CT1 and CT2 obtained after a FSL cataract surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Femtosecond cataract surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,123 participants
- Where
- 1 siteCanada
- Study dates
- 2 Feb 2017to 1 Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive cases of cataract surgery performed between January 2015 and june 2015 by a single surgeon (PH) at the clinique d'ophtalmologie Bellevue, using either the Catalys or a manual technique.
- One eye per patient, the first eye
- Uneventful cataract only
Who cannot join
- Combined glaucoma filtering surgery
- Any previous corneal surgery in this eye
- Any pathology of the interior segment
- Inflammatory eye disease of the interior segment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wound Architecture and Functional Outcome After Cataract Surgery With Manual vs. Femtosecond Laser Assisted Procedures
This study is the long term analysis of two types of FSL 3-plane corneal wound profiles, namely CT1 and CT2 obtained after a FSL cataract surgery.
Read the detailed description
Femtosecond laser cataract surgery offers several major advantages for wound construction, including high precision, repeatability and a large variety of corneal wound profiles. The aim of this study is the long term analysis of two types of FSL 3-plane corneal wound profiles, namely CT1 and CT2, CT2 being constructed with a reversed front corneal incision segment to ensure tigher wound closure and better corneal wound reapposition. The traditional manual wound performed with a standard keratome will be used as a reference. As FSL cataract surgery may be associated with a greater incidence of wound leaks at the end of surgery as compared to manual wound construction with keratomes, this study will also aim at determining wich clinical and OCT wound parameters are associated with a higher likelihood of wound leaks.
- Conditions
- Cataract
- Being tested
- Femtosecond cataract surgery
- Keywords
- Cataract, Femtosecond laser, Cornea, Anatomy, FSL, surgery
- Medical subject headings
- Cataract, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femtosecond cataract surgeryProcedure or surgery
Also called ReLACS
Catalys create a circular opening for accessing and removing the cataract.
| Study group | Role | What they receive |
|---|---|---|
| CT1 | Experimental | FLACS- Initial Wound parameters (CT1)
Sample size calculation based on woundleak incidence estimated from preliminary results:
* For CT1 vs MT, we will only need 10 per group to have 80% power assuming a 1:1 ratio of CT to MT and 5% type 1 error.
* For CT1 vs CT2, we will need 22 per group to have 80% power (assuming 60% wound leakage in CT1 and 20% wound leakage in CT2, a 1:1 ratio, and a 5% type 1 error rate)
* A total of 253 patients are eligible for this study, 101 with FLACS and 152 with Manual Cataract Surgery. We thus expect that our study population will allow adequate analysis of the main outcome parameters proposed herein. Receives: Procedure: Femtosecond cataract surgery |
| CT2 | Experimental | The revised profile CT2, consists of a wider anterior side cut angle (beveled corneal undercut) and a narrower posterior side cut angle compared to the initial CT1 profile. This new corneal incision profile is constructed to ensure a tigher wound closure and a better corneal wound reapposition.
The traditional manual wound performed with a standard keratome wil be used as a reference. Receives: Procedure: Femtosecond cataract surgery |
| MT control group | Active comparator | Standard manual technique (MT) Receives: Procedure: Femtosecond cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preservation of a physiological postoperative anatomy will be considered as a criterion of success
Change in corneal anatomy as measured by the difference between pre-and postoperative corneal profile on OCT images
Measured: 2 Months
Secondary outcomes (1)
The absence or a lower incidence of wound leak will also be considered as a criterion of success
Presence or not of a wound leak necessitating a 10.0 Nylon to stop the leak
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start2 Feb 2017
- Primary completion28 Feb 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Post market study (Phase IV)
- Masking
- None (open label)
- Enrolment
- 1,123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Paul Harasymowycz, Maisonneuve-Rosemont Hospital
- Investigators
- Paul Harasymowycz, MD, Principal investigator, Ciusss de L'Est de l'Île de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097562
- Sponsor's protocol ID
- F11a-CEMTL-3355
- Acronym
- CATALYS
- Status last verified
- Feb 2021
- First submitted
- 10 Jun 2016
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication of data and results in an Ophtalmology journal, conferences
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wound Architecture and Functional Outcome After Cataract Surgery With Manual vs. Femtosecond Laser Assisted Procedures
- ClinicalTrials.gov ID
- NCT03097562
- Acronym / sponsor ID
- CATALYS / F11a-CEMTL-3355
- Conditions
- Cataract
- Keywords
- Cataract, Femtosecond laser, Cornea, Anatomy, FSL, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,123 participants (actual)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 31 Mar 2017 (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.
This study is the long term analysis of two types of FSL 3-plane corneal wound profiles, namely CT1 and CT2 obtained after a FSL cataract surgery.
Detailed description
Femtosecond laser cataract surgery offers several major advantages for wound construction, including high precision, repeatability and a large variety of corneal wound profiles. The aim of this study is the long term analysis of two types of FSL 3-plane corneal wound profiles, namely CT1 and CT2, CT2 being constructed with a reversed front corneal incision segment to ensure tigher wound closure and better corneal wound reapposition. The traditional manual wound performed with a standard keratome will be used as a reference. As FSL cataract surgery may be associated with a greater incidence of wound leaks at the end of surgery as compared to manual wound construction with keratomes, this study will also aim at determining wich clinical and OCT wound parameters are associated with a higher likelihood of wound leaks.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Post market study (Phase IV)
| Arm | Type | Receives |
|---|---|---|
| CT1 | Experimental | Procedure: Femtosecond cataract surgeryFLACS- Initial Wound parameters (CT1) Sample size calculation based on woundleak incidence estimated from preliminary results: * For CT1 vs MT, we will only need 10 per group to have 80% power assuming a 1:1 ratio of CT to MT and 5% type 1 error. * For CT1 vs CT2, we will need 22 per group to have 80% power (assuming 60% wound leakage in CT1 and 20% wound leakage in CT2, a 1:1 ratio, and a 5% type 1 error rate) * A total of 253 patients are eligible for this study, 101 with FLACS and 152 with Manual Cataract Surgery. We thus expect that our study population will allow adequate analysis of the main outcome parameters proposed herein. |
| CT2 | Experimental | Procedure: Femtosecond cataract surgeryThe revised profile CT2, consists of a wider anterior side cut angle (beveled corneal undercut) and a narrower posterior side cut angle compared to the initial CT1 profile. This new corneal incision profile is constructed to ensure a tigher wound closure and a better corneal wound reapposition. The traditional manual wound performed with a standard keratome wil be used as a reference. |
| MT control group | Active comparator | Procedure: Femtosecond cataract surgeryStandard manual technique (MT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Consecutive cases of cataract surgery performed between January 2015 and june 2015 by a single surgeon (PH) at the clinique d'ophtalmologie Bellevue, using either the Catalys or a manual technique.
- One eye per patient, the first eye
- Uneventful cataract only
Key exclusion criteria (4 listed)
- Combined glaucoma filtering surgery
- Any previous corneal surgery in this eye
- Any pathology of the interior segment
- Inflammatory eye disease of the interior segment
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 |
|---|---|---|
| Femtosecond cataract surgeryAlso: ReLACSCatalys create a circular opening for accessing and removing the cataract. | Procedure or surgery | CT1, CT2, MT control group |
Primary outcome
Preservation of a physiological postoperative anatomy will be considered as a criterion of success
Time frame: 2 Months
Change in corneal anatomy as measured by the difference between pre-and postoperative corneal profile on OCT images
1 secondary outcome
The absence or a lower incidence of wound leak will also be considered as a criterion of success
Time frame: 2 Months
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 25 Feb 2021.
- Individual participant dataSharing planned: Yes. Publication of data and results in an Ophtalmology journal, conferences
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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.
Paul Harasymowycz, MD principal investigator
Ciusss de L'Est de l'Île de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femtosecond cataract surgery in people with Cataract, run by Maisonneuve-Rosemont Hospital 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 4 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 25 Feb 2021. 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?
Preservation of a physiological postoperative anatomy will be considered as a criterion of success (time frame: 2 Months). 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 25 Feb 2021.