CataractPhase 2/3NCT01001117
Laser Treatment of the Crystalline Lens
A Phase 2/3 study testing LensAR laser surgery and Phaco-emulsification cataract surgery in people with Cataract, run by LensAR Incorporated at 1 site in Mexico.
Trial summary
The use of a femtosecond laser in cataract surgery that gives equivalent or improved results comapred to conventional phaco-emulsification surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cataract
- What is being tested?
- LensAR laser surgery and Phaco-emulsification cataract surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteMexico
- Study dates
- Oct 2008to Apr 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 Any age
- All sexes
- No healthy volunteers
- Child, 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 foldable monofocal IOL implantation (ideally of the same type), and then elect to have the LensAR laser surgery.
- Subjects must be willing and able to return for scheduled follow-up examinations for a minimum of 12 months after surgery.
- Central 8 mm of clear cornea without vascularization.
Who cannot join
- Subjects with prior anterior segment or vitreo-retinal surgical intervention in the eye to be treated.
- Subjects with lenticular cataracts with nuclear grading greater than Grade 4 on the LOCS III scale.
- Subjects who cannot attain ocular dilation of 7.0 mm.
- Subjects with anterior segment pathology in the eye to be treated that is not directly improved by lens extraction and IOL implantation.
- Subjects with residual, recurrent, active ocular or uncontrolled eyelid disease or any corneal abnormalities (including endothelial dystrophy, guttata, recurrent corneal erosion, etc.) in the eye to be treated.
- Subjects with ophthalmoscopic signs of keratoconus (or keratoconus suspect) in the eye to be treated.
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- Subjects with a history of severe dry eye not responding to therapy.
- Subjects with macular degeneration, history of retinal detachment, or any other fundus findings that would pose a risk to safety or an acceptable visual outcome in the eye to be treated.
- Subjects with a history of herpes zoster or herpes simplex keratitis.
- Subjects who have a history of steroid-responsive rise in intraocular pressure, glaucoma, or are a glaucoma suspect.
- Subjects with diabetic retinopathy, autoimmune disease, connective tissue disease, pseudoexfoliation syndrome, or clinically significant atopic syndrome.
- Subjects on chronic systemic corticosteroids or other immunosuppressive therapy that may affect wound healing, and any immuno-compromised subjects.
- Subjects who are using ophthalmic medication(s) other than artificial tears for treatment of ocular pathology including ocular allergy.
- Subjects using systemic medications with significant ocular side effects.
- Subjects who are pregnant, lactating, or of child-bearing potential and not practicing a medically approved method of birth control.
- Subjects with known sensitivity to planned study concomitant medications.
- Subjects who are participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Asociacion Para Evitar La Cuguera en Mexico IAP
Mexico City, DF 04030
About this study
Official title: A Prospective Single-Center Clinical Trial to Evaluate the Feasibility of Laser Treatment of the Crystalline Lens in Subjects Having Elected to Undergo Lens Extraction and Intraocular Lens Implantation
The use of a femtosecond laser in cataract surgery that gives equivalent or improved results comapred to conventional phaco-emulsification surgery.
Read the detailed description
The objective of this study is to evaluate the feasibility of the LensAR laser system to surgically intervene within the crystalline lens. The primary goal of this initial study is to establish safety parameters as compared with conventional phacoemulsification procedures, and to evaluate the ability to provide an accurate and consistent anterior capsular opening (capsulotomy).
- Conditions
- Cataract
- Being tested
- LensAR laser surgery, Phaco-emulsification cataract surgery
- Keywords
- Cataract, Capsulotomy, Capsulorrhexis, 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 surgeryDevice
Also called LensAR Laser System
Use of laser for cataract surgery
Phaco-emulsification cataract surgeryDevice
Also called Exact equipment varies
Phaco-emulsification cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| Laser treated | Experimental | Eye treated with LensAR Laser System Receives: Device: LensAR laser surgery |
| Control Eye | Active comparator | Contralateral eye treated with conventional phaco-emulsification Receives: Device: Phaco-emulsification cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capsulotomy a. Ease of opening b. Achievement of intended shape and size
Measured: Time of Surgery
Lens removal a. Ease of irrigation / aspiration (time) b. Reduced ultrasound phacoemulsification
Measured: Time of surgery
Posterior capsule rupture < 10% occurrence rate
Measured: Time of Surgery
Less than 5% of eyes should lose more than two lines of BSCVA
Measured: 3 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study startOct 2008
- Primary completionOct 2009
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- LensAR Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ramon Naranjo, MD, Principal investigator, Asociacion Para Evitar La Ceguera en Mexico IAPJorge VIllar, MD, Principal investigator, Asociacion Para Evitar La Ceguera en Mexico IAP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001117
- Sponsor's protocol ID
- 52-00001-0000
- Status last verified
- Apr 2011
- First submitted
- 22 Oct 2009
- Last updated
- 15 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Tackman RN, Kuri JV, Nichamin LD, Edwards K. Anterior capsulotomy with an ultrashort-pulse laser. J Cataract Refract Surg. 2011 May;37(5):819-24. doi: 10.1016/j.jcrs.2010.11.030. Epub 2011 Mar 11.
PubMed 21397456
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
- A Prospective Single-Center Clinical Trial to Evaluate the Feasibility of Laser Treatment of the Crystalline Lens in Subjects Having Elected to Undergo Lens Extraction and Intraocular Lens Implantation
- ClinicalTrials.gov ID
- NCT01001117
- Acronym / sponsor ID
- 52-00001-0000
- Conditions
- Cataract
- Keywords
- Cataract, Capsulotomy, Capsulorrhexis, Phacoemulsification
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (actual)
- Lead sponsor
- LensAR IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Apr 2011 (estimated)
- First posted
- 23 Oct 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 use of a femtosecond laser in cataract surgery that gives equivalent or improved results comapred to conventional phaco-emulsification surgery.
Detailed description
The objective of this study is to evaluate the feasibility of the LensAR laser system to surgically intervene within the crystalline lens. The primary goal of this initial study is to establish safety parameters as compared with conventional phacoemulsification procedures, and to evaluate the ability to provide an accurate and consistent anterior capsular opening (capsulotomy).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser treated | Experimental | Device: LensAR laser surgeryEye treated with LensAR Laser System |
| Control Eye | Active comparator | Device: Phaco-emulsification cataract surgeryContralateral eye treated with conventional phaco-emulsification |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 foldable monofocal IOL implantation (ideally of the same type), and then elect to have the LensAR laser surgery.
- Subjects must be willing and able to return for scheduled follow-up examinations for a minimum of 12 months after surgery.
- Central 8 mm of clear cornea without vascularization.
Key exclusion criteria (17 listed)
- Subjects with prior anterior segment or vitreo-retinal surgical intervention in the eye to be treated.
- Subjects with lenticular cataracts with nuclear grading greater than Grade 4 on the LOCS III scale.
- Subjects who cannot attain ocular dilation of 7.0 mm.
- Subjects with anterior segment pathology in the eye to be treated that is not directly improved by lens extraction and IOL implantation.
- Subjects with residual, recurrent, active ocular or uncontrolled eyelid disease or any corneal abnormalities (including endothelial dystrophy, guttata, recurrent corneal erosion, etc.) in the eye to be treated.
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 surgeryAlso: LensAR Laser SystemUse of laser for cataract surgery | Device | Laser treated |
| Phaco-emulsification cataract surgeryAlso: Exact equipment variesPhaco-emulsification cataract surgery | Device | Control Eye |
Primary outcome
Capsulotomy a. Ease of opening b. Achievement of intended shape and size
Time frame: Time of Surgery
Lens removal a. Ease of irrigation / aspiration (time) b. Reduced ultrasound phacoemulsification
Time frame: Time of surgery
Posterior capsule rupture < 10% occurrence rate
Time frame: Time of Surgery
Less than 5% of eyes should lose more than two lines of BSCVA
Time frame: 3 months post-operative
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.
- Derived from this study: PubMed 21397456Tackman RN, Kuri JV, Nichamin LD, Edwards K. Anterior capsulotomy with an ultrashort-pulse laser. J Cataract Refract Surg. 2011 May;37(5):819-24. doi: 10.1016/j.jcrs.2010.11.030. Epub 2011 Mar 11.
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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.
Ramon Naranjo, MD principal investigator
Asociacion Para Evitar La Ceguera en Mexico IAP
Jorge VIllar, MD principal investigator
Asociacion Para Evitar La Ceguera en Mexico IAP
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 surgery and Phaco-emulsification cataract surgery 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 17 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?
Capsulotomy a. Ease of opening b. Achievement of intended shape and size (time frame: Time of Surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01001117, which also lists 1 linked publication.
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.