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

Sponsor

Maisonneuve-Rosemont Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03097562

Collaborator

(none)

1,123

Enrollment

Location

Arms

43.9

Actual Duration (Months)

25.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Procedure: Femtosecond cataract surgery	N/A

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

Study Type:

Interventional

Actual Enrollment :

1123 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Post market study (Phase IV)Post market study (Phase IV)

Masking:

None (Open Label)

Masking Description:

Consecutive patients who underwent cataract surgery using one of the following three types of surgical wound will be compared: Catalys - Initial wound parameters Catalys - Revised wound parameters Standard manual technique (MT control group)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Feb 2, 2017

Actual Primary Completion Date :

Feb 28, 2020

Actual Study Completion Date :

Oct 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CT1 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 Catalys create a circular opening for accessing and removing the cataract. Other Names: ReLACS
Experimental: CT2 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 Catalys create a circular opening for accessing and removing the cataract. Other Names: ReLACS
Active Comparator: MT control group Standard manual technique (MT)	Procedure: Femtosecond cataract surgery Catalys create a circular opening for accessing and removing the cataract. Other Names: ReLACS

Arm

Intervention/Treatment

Experimental: CT1

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

Catalys create a circular opening for accessing and removing the cataract.

Other Names:

ReLACS

Experimental: CT2

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

Catalys create a circular opening for accessing and removing the cataract.

Other Names:

ReLACS

Active Comparator: MT control group

Standard manual technique (MT)

Procedure: Femtosecond cataract surgery

Catalys create a circular opening for accessing and removing the cataract.

Other Names:

ReLACS

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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