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

Cataract Clinical Trial

— CATALYS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03097562
• Other study ID #: F11a-CEMTL-3355
• Status: Completed
• Phase: N/A
• Start date: February 2, 2017
• Est. completion date: October 1, 2020

Study information

• Verified date: February 2021
• Source: Maisonneuve-Rosemont Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1123
• Est. completion date: October 1, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract

Intervention

Procedure:
• Femtosecond cataract surgery
Catalys create a circular opening for accessing and removing the cataract.

Locations

Country	Name	City	State
Canada	Montreal Glaucoma Institut	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Maisonneuve-Rosemont Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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