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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT1 | Experimental | FLACS- Initial Wound parameters (CT1) Sample size calculation based on woundleak incidence estimated from preliminary results:
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| 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. |
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| MT control group | Active Comparator | Standard manual technique (MT) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Femtosecond cataract surgery | Procedure | Catalys create a circular opening for accessing and removing the cataract. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Harasymowycz, MD | Ciusss de L'Est de l'Île de Montréal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal Glaucoma Institut | Montreal | Quebec | H1V 1G5 | Canada |
Publication of data and results in an Ophtalmology journal, conferences
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D003316 | Corneal Diseases |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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Post market study (Phase IV)
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Consecutive patients who underwent cataract surgery using one of the following three types of surgical wound will be compared:
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