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

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

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Procedure: Femtosecond 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.

• Study Type: Interventional
• Enrollment (Actual): 1123
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H1V 1G5
      • Montreal Glaucoma Institut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Maisonneuve-Rosemont Hospital
• Investigators: Principal Investigator: Paul Harasymowycz, MD, Ciusss de L'Est de l'Île de Montréal

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2017
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: June 10, 2016
• First Submitted That Met QC Criteria: March 27, 2017
• First Posted (Actual): March 31, 2017

Study Record Updates

• Last Update Posted (Actual): February 25, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: surgery; Cataract; Femtosecond laser; Cornea; Anatomy; FSL
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Capsule Opacification
• Other Study ID Numbers: F11a-CEMTL-3355

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Publication of data and results in an Ophtalmology journal, conferences

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No