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

Not Applicable

Completed

• Conditions: Cataract

• 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

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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