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

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Procedure: Femtosecond cataract surgery

• Registration Number: NCT03097562
• Lead Sponsor: Maisonneuve-Rosemont Hospital

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.

Study Timeline

• Study First Submitted: 2016-06-10
• Study Start: 2017-02-02
• Study First Submitted QC: 2017-03-27
• Study First Posted: 2017-03-31
• Primary Completion: 2020-02-28
• Study Completion: 2020-10-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-24
• Last Update Posted: 2021-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1123

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT2	Femtosecond cataract surgery	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.
MT control group	Femtosecond cataract surgery	Standard manual technique (MT)
CT1	Femtosecond cataract surgery	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Montreal Glaucoma Institut; 🇨🇦 Montreal, Quebec, Canada