Cataract
Conditions
Keywords
Cataract, Femtosecond laser, Cornea, Anatomy, FSL, surgery
Brief 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.
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.
Interventions
PROCEDUREFemtosecond cataract surgery
Catalys create a circular opening for accessing and removing the cataract.
Sponsors
Maisonneuve-Rosemont Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
Consecutive patients who underwent cataract surgery using one of the following three types of surgical wound will be compared: 1. Catalys - Initial wound parameters 2. Catalys - Revised wound parameters 3. Standard manual technique (MT control group)
Intervention model description
Post market study (Phase IV)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Combined glaucoma filtering surgery * Any previous corneal surgery in this eye * Any pathology of the interior segment * Inflammatory eye disease of the interior segment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preservation of a physiological postoperative anatomy will be considered as a criterion of success | 2 Months | Change in corneal anatomy as measured by the difference between pre-and postoperative corneal profile on OCT images |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The absence or a lower incidence of wound leak will also be considered as a criterion of success | 2 Months | Presence or not of a wound leak necessitating a 10.0 Nylon to stop the leak |
Countries
Canada
Outcome results
None listed