Wound Architecture and Functional Outcome After Cataract Surgery With Manual vs.Femtosecond Laser Assisted Procedures

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Wound Architecture and Functional Outcome After Cataract Surgery With Manual vs. Femtosecond Laser Assisted Procedures

Conditions
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Cataract

Intervention / Treatment
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* Procedure: Femtosecond cataract surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Post market study (Phase IV)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT1<br>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<br>* Catalys create a circular opening for accessing and removing the cataract.<br>* Other names: ReLACS;|
| Experimental: CT2<br>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<br>* Catalys create a circular opening for accessing and removing the cataract.<br>* Other names: ReLACS;|
| Active Comparator: MT control group<br>Standard manual technique (MT) | Procedure: Femtosecond cataract surgery<br>* Catalys create a circular opening for accessing and removing the cataract.<br>* Other names: ReLACS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract, FSL, Femtosecond laser, Cornea, Anatomy, surgery