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

NCT03097562 | Completed DMC

• 1 other identifier: F11a-CEMTL-3355
• Study Type: interventional
• Target: 1,123
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Keywords

Cataract; Femtosecond laser; Cornea; Anatomy; FSL; surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The absence or a lower incidence of wound leak will also be considered as a criterion of success

  2 Months

Study Arms (3)

CT1

EXPERIMENTAL

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

CT2

EXPERIMENTAL

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

MT control group

ACTIVE COMPARATOR

Standard manual technique (MT)

Procedure: Femtosecond cataract surgery

Interventions

Femtosecond cataract surgery PROCEDURE

Catalys create a circular opening for accessing and removing the cataract.

Also known as: ReLACS

CT1; CT2; MT control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Combined glaucoma filtering surgery
• Any previous corneal surgery in this eye
• Any pathology of the interior segment
• Inflammatory eye disease of the interior segment

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead

Study Sites (1)

Montreal Glaucoma Institut

Montreal, Quebec, H1V 1G5, Canada

Location

MeSH Terms

Conditions

Cataract; Corneal Diseases

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Paul Harasymowycz, MD

  Ciusss de L'Est de l'Île de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Consecutive patients who underwent cataract surgery using one of the following three types of surgical wound will be compared: 1. Catalys - Initial wound parameters 2. Catalys - Revised wound parameters 3. Standard manual technique (MT control group)
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Glaucoma Service University of Montreal

Model Details: Post market study (Phase IV)

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: March 31, 2017
• Study Start: February 2, 2017
• Primary Completion: February 28, 2020
• Study Completion: October 1, 2020
• Last Updated: February 25, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)