CataractNCT00959322
A Prospective Single Center Clinical Study for Capsulotomy Using the LenSx 550 Laser
A study testing LenSx 550 Laser System in people with Cataract, run by LenSx Lasers Inc. at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- LenSx 550 Laser System
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteHungary
- Study dates
- Aug 2008to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cataract
- Being tested
- LenSx 550 Laser System
- Keywords
- Capsulotomy
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenSx 550 Laser SystemDevice
Also called LenSx, LenSx 550 Laser, Femtosecond
Femtosecond laser used to create capsulotomy incision.
What is being measured
The primary outcome is the main question the study is designed to answer.
Capsulotomy is complete
Measured: 1 day, 1 week, 1 month
Secondary outcomes (1)
No radial tears noted intraoperatively
Measured: 1 day, 1 week, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2009 (estimated)
- Study startAug 2008
- Primary completionFeb 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- LenSx Lasers Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ronald M Kurtz, M.D., Study chair, LenSx Lasers Inc.Melvin Sarayba, M.D., Study director, LenSx Lasers Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959322
- Sponsor's protocol ID
- CAP-001
- Status last verified
- Oct 2009
- First submitted
- 12 Aug 2009
- Last updated
- 14 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single Center Clinical Study for Capsulotomy Using the LenSx 550 Laser
- ClinicalTrials.gov ID
- NCT00959322
- Acronym / sponsor ID
- CAP-001
- Conditions
- Cataract
- Keywords
- Capsulotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- LenSx Lasers Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 14 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 24 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenSx 550 Laser SystemAlso: LenSx, LenSx 550 Laser, FemtosecondFemtosecond laser used to create capsulotomy incision. | Device | – |
Primary outcome
Capsulotomy is complete
Time frame: 1 day, 1 week, 1 month
1 secondary outcome
No radial tears noted intraoperatively
Time frame: 1 day, 1 week, 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald M Kurtz, M.D. study chair
LenSx Lasers Inc.
Melvin Sarayba, M.D. study director
LenSx Lasers Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LenSx 550 Laser System in people with Cataract, run by LenSx Lasers Inc. at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Capsulotomy is complete (time frame: 1 day, 1 week, 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2009.