CClinicalTrials.gg
CompletedNCT00959322Updated Oct 14, 2009

A Prospective Single Center Clinical Study for Capsulotomy Using the LenSx 550 Laser

An interventional study of LenSx 550 Laser System in Cataract, sponsored by LenSx Lasers Inc.. Completed at 1 site in Hungary. Open to participants aged 24 Years and older. Per ClinicalTrials.gov, last updated 2009-10-14.

Sponsored by LenSx Lasers Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
24 Years and older
Sex
All
01

Study summary

The LenSx 550 laser system is a femtosecond laser intended for use in performing anterior capsulotomy during cataract surgery. The anterior capsulotomy creates a circular opening in the anterior surface of the capsular bag that contains the cataractous crystalline lens. The objective of this study is to evaluate the ability of the LenSx 550 laser to successfully perform anterior capsulotomy during cataract surgery.

02

Conditions studied

  • Cataract

Browse trials for

Keywords

  • Capsulotomy
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 60 is below the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

LenSx Lasers Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
24 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Must be eligible to undergo cataract extraction by phacoemulsification with primary intraocular lens implantation in at least 1 eye.
  • Must be at least 24 years of age.
  • Must be willing and able to return for scheduled follow-up examinations.
  • Subjects must sign and be given a copy of the written Informed Consent form.

Exclusion criteria

Exclusion Criteria:

  • Corneal disease or pathology that precludes applanation of the cornea or transmission of laser wavelength or distortion of laser light.
  • Subjects with a poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally are excluded.
  • Subjects with residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease) in either eye are excluded.
  • History of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP>21 mm Hg in either eye.
  • Lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.
  • Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye.
  • Subjects who are pregnant, lactating, or planning to be pregnant during the course of the study.
  • Known sensitivity to planned study concomitant medications.
  • Subjects participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.
  • Subjects presenting any contraindications to cataract surgery.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Interventions

  • DeviceLenSx 550 Laser System

    Femtosecond laser used to create capsulotomy incision.

    Also known as: LenSx, LenSx 550 Laser, Femtosecond

06

What researchers measure

Primary outcomes

  1. Capsulotomy is complete

    Time frame: 1 day, 1 week, 1 month

Secondary outcomes

  1. No radial tears noted intraoperatively

    Time frame: 1 day, 1 week, 1 month

07

Study locations

1 site
  • Semmelweis University
    Budapest, 1085, Hungary
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00959322
Lead sponsor
LenSx Lasers Inc.
First posted
Aug 14, 2009
Start date
Aug 2008
Primary completion
Feb 2009
Completion
Mar 2009
Last update
Oct 14, 2009

Study contacts

Ronald M Kurtz, M.D.
study chair · LenSx Lasers Inc.
Melvin Sarayba, M.D.
study director · LenSx Lasers Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion