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Completed

NCT Number: NCT02396719

A Real-World Registry to Investigate the Performance of LenSx® Laser in Chinese Patients

The purpose of this study is to investigate the performance of LenSx® Laser in femtosecond laser-assisted cataract surgery (FLACS) in real-world medical practice in Chinese patients.

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Key information

Conditions

Cataracts Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alcon China Ophthalmic Product Co., Ltd.

Beijing, 100016, China

About this study

All subjects will undergo FLACS using the LenSx® Laser system. The recommended postoperative visits will follow the current standard of care in China.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chinese;
  • Will undergo LenSx® Laser-assisted cataract surgery and phacoemulsification in at least one eye;
  • Must sign written informed consent;
  • Other protocol-specified inclusion criteria may apply.

Exclusion criteria

  • Contraindications listed in LenSx® Laser System Operator's Manual;
  • Pregnant, nursing, or planning a pregnancy;
  • Concurrent enrollment in another investigational drug and/or device study or participation in such a study within 30 days prior to surgery day;
  • Other protocol-specified exclusion criteria may apply.

Treatment and study plan

LenSx® Laser

Device

Used for cornea incision, capsulotomy and lens fragmentation during cataract surgery

Primary outcomes

  1. Completion rate of a round anterior capsulotomy

    Time frame: Surgery (Day 0)

Secondary outcomes

  1. Completion rate of lens fragmentation without additional segmentation after LenSx Laser procedure

    Time frame: Surgery (Day 0)

  2. Completion rate of intraocular lens (IOL) implantation

    Time frame: Surgery (Day 0)

  3. Completion rate of corneal incisions

    Time frame: Surgery (Day 0)

  4. Best-corrected distance visual acuity (BCDVA)

    Time frame: Up to Day 30

  5. Percentage of patients with BCDVA of 20/20, 20/25, 20/40 or better at each visit

    Time frame: Up to Day 30

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

A Prospective, Single-Arm, Multicenter, Registry Study to Investigate the Performance of Femtosecond Laser-Assisted Cataract Surgery in Chinese Cataract Patients

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 24, 2015
Registry last updated
Jun 6, 2016

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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