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Completed

NCT Number: NCT03097562

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

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.

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Key information

Conditions

Cataract Corneal Diseases Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montreal Glaucoma Institut

Montreal, Quebec, H1V 1G5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Femtosecond Cataract Surgery

Procedure

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

Other names: ReLACS

Primary outcomes

  1. Preservation of a physiological postoperative anatomy will be considered as a criterion of success

    Time frame: 2 Months

    Change in corneal anatomy as measured by the difference between pre-and postoperative corneal profile on OCT images

Secondary outcomes

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

    Time frame: 2 Months

    Presence or not of a wound leak necessitating a 10.0 Nylon to stop the leak

Sponsors and collaborators

Lead sponsor

Maisonneuve-Rosemont Hospital

Other

Registry information

Official study title

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

Acronym: CATALYS

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 31, 2017
Registry last updated
Feb 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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