Prospective Clinical Trial of the LensAR Laser System

Cataract Clinical Trial

Official title:

Prospective Clinical Trial of the LensAR Laser System in the Treatment of Cataracts of Different Grades of Maturity

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01014702
• Other study ID #: 52-00006-000
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: November 13, 2009
• Last updated: April 14, 2011
• Start date: November 2009
• Est. completion date: June 2011

Study information

• Verified date: April 2011
• Source: LensAR Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Protection Against Health Risks
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

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 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• LensAR Laser System
Use of laser for capsulotomy and lens fragmentation
• Conventional phacoemulsification
Use of standard techniques for capsulotomy and lens fragmentation

Locations

Country	Name	City	State
Mexico	Asociacion para Evitar la Ceguera en Mexico IAP	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
LensAR Incorporated

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completeness and ease of opening of capsulotomy		Day 0 (Surgery)	No
Primary	Reduced need for ultrasound phacoemulsification compared to control eye		Day 0 (surgery)	No
Primary	Rate of adverse events		3 months	Yes