An interventional study of Femtosecond cataract surgery in Cataract, sponsored by Maisonneuve-Rosemont Hospital. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-25.
Sponsored by Maisonneuve-Rosemont Hospital · Not applicable, Interventional, and Health services research
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Among 33 studies in Cataract with a site in Canada — 3 open to participants now, 3 under way, none of them phase 3. Cataract · Canada.
Among the 33 studies in Cataract with a site in Canada, this one is the 2nd largest by enrollment of the 23 interventional ones that give a count, is one of 3 that started in 2017, is one of 18 with no phase, and was the 12th registered.
1,630 studies on the registry are indexed under Cataract; 235 are open to participants now.
Browse Cataract studies →3 of the 33 studies in Cataract with a site in Canada are open now. Recruiting first, the newest first:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Sites in Canada
Ages 65+ · Healthy volunteers
Bochner Eye Institute · Sites in Canada
Ages 50+
Uptown Eye Specialists · Sites in Canada
Ages 18+
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 142 Cataract studies recruiting now, 88 (62%) set no upper age limit and 8 (6%) stop at 75 or younger; 10 take children under 18; 16 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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33 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 3 started in 2017.
This study's enrollment of 1,123 is above the median of 79 across 1,093 interventional studies indexed under Cataract.
Median enrollment 68 across the 23 interventional studies, 123 across the 10 observational. Of the 22 that completed or were terminated, 6 (27%) have results posted.
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6 of 33 have an industry lead sponsor. The 10 most frequent:
Maisonneuve-Rosemont Hospital is the lead sponsor of 73 studies on the registry; 4 are open to participants now.
Maisonneuve-Rosemont Hospital has 1 study filed under Cataract — fewer than ten, so there is no comparison to draw.
2 of the studies in Cataract with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07404293Bochner Eye InstituteZero CDE Technique for Lens Removal During FLACS | 2027-03-14 |
| NCT07714174Samuel Lunenfeld Research Institute, Mount Sinai HospitalPost-operative Cognitive Decline After Ambulatory Cataract Surgery in the Elderly Population | 2027-11-01 |
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Among the 33 studies in Cataract with a site in Canada, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
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Exclusion Criteria:
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.
Procedure: Femtosecond cataract surgery
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.
Procedure: Femtosecond cataract surgery
Standard manual technique (MT)
Procedure: Femtosecond cataract surgery
Catalys create a circular opening for accessing and removing the cataract.
Also known as: ReLACS
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
Time frame: 2 Months
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
Time frame: 2 Months
Plan to share: Yes — Publication of data and results in an Ophtalmology journal, conferences
No publications or documents are linked to this record.
Ran from Feb 2017 to primary completion in Feb 2020, 36 months.
Of 302 non-industry interventional studies with no phase under Cataract, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's 36 months is above that.
Counting every sponsor, half of 492 studies reached it within 17 months; a quarter within 9 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Maisonneuve-Rosemont Hospital