search
Back to results

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

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Femtosecond cataract surgery
Sponsored by
Maisonneuve-Rosemont Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cataract focused on measuring Cataract, Femtosecond laser, Cornea, Anatomy, FSL, surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Montreal Glaucoma Institut

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

CT1

CT2

MT control group

Arm 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.

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.

Standard manual technique (MT)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 10, 2016
Last Updated
February 24, 2021
Sponsor
Maisonneuve-Rosemont Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03097562
Brief Title
Wound Architecture and Functional Outcome After Cataract Surgery With Manual vs.Femtosecond Laser Assisted Procedures
Acronym
CATALYS
Official Title
Wound Architecture and Functional Outcome After Cataract Surgery With Manual vs. Femtosecond Laser Assisted Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 2, 2017 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maisonneuve-Rosemont Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract, Femtosecond laser, Cornea, Anatomy, FSL, surgery

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Post market study (Phase IV)
Masking
None (Open Label)
Masking Description
Consecutive patients who underwent cataract surgery using one of the following three types of surgical wound will be compared: Catalys - Initial wound parameters Catalys - Revised wound parameters Standard manual technique (MT control group)
Allocation
Non-Randomized
Enrollment
1123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CT1
Arm Type
Experimental
Arm 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.
Arm Title
CT2
Arm Type
Experimental
Arm 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.
Arm Title
MT control group
Arm Type
Active Comparator
Arm Description
Standard manual technique (MT)
Intervention Type
Procedure
Intervention Name(s)
Femtosecond cataract surgery
Other Intervention Name(s)
ReLACS
Intervention Description
Catalys create a circular opening for accessing and removing the cataract.
Primary Outcome Measure Information:
Title
Preservation of a physiological postoperative anatomy will be considered as a criterion of success
Description
Change in corneal anatomy as measured by the difference between pre-and postoperative corneal profile on OCT images
Time Frame
2 Months
Secondary Outcome Measure Information:
Title
The absence or a lower incidence of wound leak will also be considered as a criterion of success
Description
Presence or not of a wound leak necessitating a 10.0 Nylon to stop the leak
Time Frame
2 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Harasymowycz, MD
Organizational Affiliation
Ciusss de L'Est de l'Île de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal Glaucoma Institut
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1V 1G5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Publication of data and results in an Ophtalmology journal, conferences

Learn more about this trial

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

We'll reach out to this number within 24 hrs