Feasibility Study of Laser Treatment of the Crystalline Lens to Correct Presbyopia

NCT01062412 | Terminated

• 1 other identifier: 52-00013-000 Rev C
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Presbyopia; Cataract

Keywords

Accommodation; Presbyopia; Crystalline lens

Outcome Measures

Primary Outcomes (1)

• Increased objective amplitude of accommodation

  1 month

Secondary Outcomes (1)

• Rate of adverse events

  1 month

Interventions

LensAR Laser System DEVICE

Laser treatment of the crystalline lens

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• LensAR Incorporated: lead

Study Sites (1)

Asian Eye Institute

Makati City, 1200, Philippines

Location

MeSH Terms

Conditions

Presbyopia; Cataract

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Lens Diseases

Study Officials

• Harvey S Uy, MD

  Asian Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2010
• First Posted: February 4, 2010
• Study Start: December 1, 2009
• Primary Completion: October 4, 2011
• Study Completion: October 4, 2011
• Last Updated: March 21, 2022

Record last verified: 2022-03

Locations

PH (1)