PresbyopiaNCT01062412
Feasibility Study of Laser Treatment of the Crystalline Lens to Correct Presbyopia
A study testing LensAR Laser System in people with Presbyopia and Cataract, run by LensAR Incorporated at 1 site in Philippines.
Trial summary
The study will evaluate whether the LensAR laser system can be used in the lens of the eye to increase the ability to read and/or see near objects Read more about this study
- Who is it for?
- Ages 45 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbyopia, Cataract
- What is being tested?
- LensAR Laser System
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 sitePhilippines
- Study dates
- Dec 2009to 4 Oct 2011
- 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 45 to 60 years
- All sexes
- Healthy volunteers accepted
- 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 to treat their ocular disorder then elect to have the LensAR laser surgery as part of the procedure.
- Cataract should not exceed LOCS III Grade 2.
- Subjects must have best corrected distance visual acuity of 20/40 or better in the eye to be treated .
- Subjects must be ≥ 45 years and ≤ 60 years of age at time of subject eligibility visit.
- Subjects must be willing and able to return for scheduled follow up examinations for 6 months after cataract surgery or up to 3 years (at 6 month intervals) if no cataract surgery is performed.
- Subject must have central 7 mm of clear cornea without vascularization
Who cannot join
- Subjects who are pregnant, lactating, or planning to become pregnant during the course of the study.
- 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.
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- 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.
- Subjects who cannot attain ocular dilation adequate to allow laser treatment within the minimum range based on the laser procedure to be applied.
- Subjects with known sensitivity to planned study concomitant medications.
- Subjects using systemic medication that is known to reduce the amplitude of accommodation (such as medication for motion sickness containing hyoscine or other antimuscarinic drugs, anticholinergic drugs, anti-psychotic drugs, tricyclic antidepressants and other drugs acting on the central nervous system).
- Subjects 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.
About this study
Official title: A Single Center, Prospective Clinical Trial to Evaluate the Feasibility of Laser Treatment of the Crystalline Lens to Correct Presbyopia: Philippines
The study will evaluate whether the LensAR laser system can be used in the lens of the eye to increase the ability to read and/or see near objects
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 to improve vision by increasing amplitude of accommodation in patients having elected to undergo lens extraction and IOL implantation
- Conditions
- Presbyopia, Cataract
- Being tested
- LensAR Laser System
- Keywords
- Accommodation, Presbyopia, Crystalline lens
- Medical subject headings
- Presbyopia, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LensAR Laser SystemDevice
Laser treatment of the crystalline lens
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased objective amplitude of accommodation
Measured: 1 month
Secondary outcomes (1)
Rate of adverse events
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startDec 2009
- Primary completion4 Oct 2011
- Study completion4 Oct 2011
Why it stopped: No improvement in near vision was detected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyopiaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- LensAR Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Harvey S Uy, MD, Principal investigator, Asian Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062412
- Sponsor's protocol ID
- 52-00013-000 Rev C
- Status last verified
- Mar 2022
- First submitted
- 3 Feb 2010
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Prospective Clinical Trial to Evaluate the Feasibility of Laser Treatment of the Crystalline Lens to Correct Presbyopia: Philippines
- ClinicalTrials.gov ID
- NCT01062412
- Acronym / sponsor ID
- 52-00013-000 Rev C
- Conditions
- Presbyopia, Cataract
- Keywords
- Accommodation, Presbyopia, Crystalline lens
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No improvement in near vision was detected
- Enrolment
- 80 participants (actual)
- Lead sponsor
- LensAR IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- 4 Oct 2011 (actual)
- Study completion
- 4 Oct 2011 (actual)
- First posted
- 4 Feb 2010 (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 study will evaluate whether the LensAR laser system can be used in the lens of the eye to increase the ability to read and/or see near objects
Detailed description
The objective of this study is to evaluate the feasibility of the LensAR Laser System to surgically intervene within the crystalline lens to improve vision by increasing amplitude of accommodation in patients having elected to undergo lens extraction and IOL implantation
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 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 to treat their ocular disorder then elect to have the LensAR laser surgery as part of the procedure.
- Cataract should not exceed LOCS III Grade 2.
- Subjects must have best corrected distance visual acuity of 20/40 or better in the eye to be treated .
- Subjects must be ≥ 45 years and ≤ 60 years of age at time of subject eligibility visit.
Key exclusion criteria (12 listed)
- Subjects who are pregnant, lactating, or planning to become pregnant during the course of the study.
- 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.
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 SystemLaser treatment of the crystalline lens | Device | – |
Primary outcome
Increased objective amplitude of accommodation
Time frame: 1 month
1 secondary outcome
Rate of adverse events
Time frame: 1 month
Results and safety
The study was stopped early (reason given: No improvement in near vision was detected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
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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.
Harvey S Uy, MD principal investigator
Asian Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LensAR Laser System in people with Presbyopia and Cataract, run by LensAR Incorporated at 1 site in Philippines.
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 7 inclusion and 12 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: stopped early, as of the sponsor's last update on 21 Mar 2022. 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 Philippines. 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 was stopped early (reason given: No improvement in near vision was detected). 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?
Increased objective amplitude of accommodation (time frame: 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 21 Mar 2022.