CataractPhase 2/3NCT01014702
Prospective Clinical Trial of the LensAR Laser System
A Phase 2/3 study testing LensAR Laser System and Conventional phacoemulsification in people with Cataract, run by LensAR Incorporated at 1 site in Mexico.
Trial summary
The LensAR Laser System is used to create an opening in the anterior capsule of the lens and fragments the cataractous lens. The study will evaluate clinical outcomes compared to the contra-lateral eye treated with conventional phacoemulsification surgery. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- LensAR Laser System and Conventional phacoemulsification
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteMexico
- Study dates
- Nov 2009to Jun 2011
- Phase
- Phase 2/3
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must sign and be given a copy of the written informed consent form
- Subjects must have elected to undergo lens extraction and IOL implantation and then elect to have the LensAR laser surgery as part of the procedure.
- Subjects must be willing and able to return for scheduled follow-up examinations for 6 months after surgery.
- Subjects must have central 7 mm of clear cornea without vascularization.
Who cannot join
- Subjects who have undergone previous corneal or intraocular surgery in the eye to be treated.
- Subjects with a history, signs or symptoms of ocular disease or atypical finding which would be contraindicated under standard of care for cataract surgery.
- Diabetic or hypertensive subjects with clinical evidence of retinal pathology.
- Subjects with macular degenerative pathology.
- Subjects with a history of steroid-responsive rise in IOP or uncontrolled glaucoma in either eye.
- Subjects with known lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.
- Subjects with corneal disease or pathology that precludes applanation of the cornea or transmission of laser wavelength or distortion of laser light.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Clinical Trial of the LensAR Laser System in the Treatment of Cataracts of Different Grades of Maturity
The LensAR Laser System is used to create an opening in the anterior capsule of the lens and fragments the cataractous lens. The study will evaluate clinical outcomes compared to the contra-lateral eye treated with conventional phacoemulsification surgery.
- Conditions
- Cataract
- Being tested
- LensAR Laser System, Conventional phacoemulsification
- Keywords
- Cataract, Capsulotomy, Capsulorrhexis, lens fragmentation, phacoemulsification
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LensAR Laser SystemDevice
Use of laser for capsulotomy and lens fragmentation
Conventional phacoemulsificationDevice
Use of standard techniques for capsulotomy and lens fragmentation
| Study group | Role | What they receive |
|---|---|---|
| Laser Treatment | Experimental | Not described Receives: Device: LensAR Laser System |
| Phacoemulsifcation | Active comparator | Not described Receives: Device: Conventional phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completeness and ease of opening of capsulotomy
Measured: Day 0 (Surgery)
Reduced need for ultrasound phacoemulsification compared to control eye
Measured: Day 0 (surgery)
Rate of adverse events
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LensAR Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01014702
- Sponsor's protocol ID
- 52-00006-000
- Status last verified
- Apr 2011
- First submitted
- 13 Nov 2009
- Last updated
- 15 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Trial of the LensAR Laser System in the Treatment of Cataracts of Different Grades of Maturity
- ClinicalTrials.gov ID
- NCT01014702
- Acronym / sponsor ID
- 52-00006-000
- Conditions
- Cataract
- Keywords
- Cataract, Capsulotomy, Capsulorrhexis, lens fragmentation, phacoemulsification
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- LensAR IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 17 Nov 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 LensAR Laser System is used to create an opening in the anterior capsule of the lens and fragments the cataractous lens. The study will evaluate clinical outcomes compared to the contra-lateral eye treated with conventional phacoemulsification surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser Treatment | Experimental | Device: LensAR Laser System |
| Phacoemulsifcation | Active comparator | Device: Conventional phacoemulsification |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must sign and be given a copy of the written informed consent form
- Subjects must have elected to undergo lens extraction and IOL implantation and then elect to have the LensAR laser surgery as part of the procedure.
- Subjects must be willing and able to return for scheduled follow-up examinations for 6 months after surgery.
- Subjects must have central 7 mm of clear cornea without vascularization.
Key exclusion criteria (7 listed)
- Subjects who have undergone previous corneal or intraocular surgery in the eye to be treated.
- Subjects with a history, signs or symptoms of ocular disease or atypical finding which would be contraindicated under standard of care for cataract surgery.
- Diabetic or hypertensive subjects with clinical evidence of retinal pathology.
- Subjects with macular degenerative pathology.
- Subjects with a history of steroid-responsive rise in IOP or uncontrolled glaucoma in either eye.
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 |
|---|---|---|
| LensAR Laser SystemUse of laser for capsulotomy and lens fragmentation | Device | Laser Treatment |
| Conventional phacoemulsificationUse of standard techniques for capsulotomy and lens fragmentation | Device | Phacoemulsifcation |
Primary outcome
Completeness and ease of opening of capsulotomy
Time frame: Day 0 (Surgery)
Reduced need for ultrasound phacoemulsification compared to control eye
Time frame: Day 0 (surgery)
Rate of adverse events
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing LensAR Laser System and Conventional phacoemulsification in people with Cataract, run by LensAR Incorporated at 1 site in Mexico.
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 7 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: status not confirmed, as of the sponsor's last update on 15 Apr 2011. 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 Mexico. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Completeness and ease of opening of capsulotomy (time frame: Day 0 (Surgery)). The study lists 3 primary outcomes in all. 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 15 Apr 2011.