Cataract Clinical Trial
Official title:
A Single Center, Prospective Clinical Trial to Evaluate the Feasibility of Laser Treatment of the Crystalline Lens to Correct Presbyopia: Philippines
Verified date | March 2022 |
Source | LensAR Incorporated |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Terminated |
Enrollment | 80 |
Est. completion date | October 4, 2011 |
Est. primary completion date | October 4, 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 45 Years to 60 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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. - 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. |
Country | Name | City | State |
---|---|---|---|
Philippines | Asian Eye Institute | Makati City |
Lead Sponsor | Collaborator |
---|---|
LensAR Incorporated |
Philippines,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Increased objective amplitude of accommodation | 1 month | ||
Secondary | Rate of adverse events | 1 month |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04685538 -
Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification.
|
Phase 3 | |
Recruiting |
NCT06060041 -
IC-8 Apthera IOL New Enrollment Post Approval Study
|
||
Recruiting |
NCT05518539 -
Evaluation of Quality of Vision and Visual Outcomes With Bilateral Implantation of the Clareon PanOptix Intraocular Lens
|
||
Recruiting |
NCT05271942 -
Tilt and Tumble vs Divide and Conquer - a Unique Comparison of the Two Cataract Surgery Methods
|
N/A | |
Active, not recruiting |
NCT04778501 -
PMCF Study on Monofocal Toric IOL (PODEYE TORIC) in Asia
|
N/A | |
Completed |
NCT05062564 -
Efficacy of LipiFlow in Patients Affected by Meibomian Gland Dysfunction in Reducing Post-cataract Surgery Dry Eye
|
N/A | |
Completed |
NCT03751033 -
Influence of DisCoVisc Ophthalmic Viscosurgical Device (OVD) on Intraoperative Aberrometry Readings
|
N/A | |
Completed |
NCT02529488 -
Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting Intraocular Lens (IOL) Model TFNT00
|
N/A | |
Completed |
NCT04539548 -
A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract
|
Phase 3 | |
Completed |
NCT03740659 -
Evaluation Of Aqueous Humor Of Levofloxacin-Dexamethasone Eye Drops And Of Its Components In Patients Undergoing Cataract Surgery
|
Phase 2 | |
Completed |
NCT03494257 -
Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification
|
N/A | |
Completed |
NCT05119127 -
Rotational Stability of Acrysof IQ Vivity Extended Vision Toric IOL and Refractive Visual Outcome.
|
N/A | |
Active, not recruiting |
NCT04271709 -
Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT)
|
N/A | |
Recruiting |
NCT03713268 -
Intraoperative OCT Guidance of Intraocular Surgery II
|
||
Completed |
NCT03739528 -
Levo-Dexa vs. Tobra+Dexa for Prevention and Treatment of Inflammation and Prevention of Infection in Cataract Surgery
|
Phase 3 | |
Completed |
NCT02888210 -
A Study Assessing Safety and Efficacy of MD-15 Intraocular Lens in Patients With Aphakic Eye After Cataract Surgery
|
Phase 3 | |
Completed |
NCT03356847 -
Evaluation of the Rotational Stability of the Monofocal SISA Implant Following Cataract Surgery
|
N/A | |
Completed |
NCT04332640 -
Clinical Evaluation of the Next Generation Phaco System
|
N/A | |
Recruiting |
NCT03638726 -
Subconjunctival Atropine and Intracameral Epinephrine for Pupil Dilation in Phacoemulsification
|
Phase 4 | |
Completed |
NCT03050697 -
Evaluation of the Safety and Performance of the HARMONI® Toric Lens
|
N/A |