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

Maisonneuve-Rosemont Hospital

Status: Completed

Conditions: Cataract

Treatments: Procedure: Femtosecond cataract surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03097562

F11a-CEMTL-3355

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,123 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,123 participants in 3 patient groups

CT1

Experimental group

Description:

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.

Treatment:

Procedure: Femtosecond cataract surgery

CT2

Experimental group

Description:

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.

Treatment:

Procedure: Femtosecond cataract surgery

MT control group

Active Comparator group

Description:

Standard manual technique (MT)

Treatment:

Procedure: Femtosecond cataract surgery