Laser Treatment of the Crystalline Lens

Cataract Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01001117
• Other study ID #: 52-00001-0000
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: October 22, 2009
• Last updated: April 14, 2011
• Start date: October 2008
• Est. completion date: April 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 use of a femtosecond laser in cataract surgery that gives equivalent or improved results comapred to conventional phaco-emulsification surgery.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: April 2011
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A 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 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.

Exclusion Criteria:

• 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.

• 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.

Study Design

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• LensAR laser surgery
Use of laser for cataract surgery
• Phaco-emulsification cataract surgery
Phaco-emulsification cataract surgery

Locations

Country	Name	City	State
Mexico	Asociacion Para Evitar La Cuguera 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	Capsulotomy a. Ease of opening b. Achievement of intended shape and size		Time of Surgery	No
Primary	Lens removal a. Ease of irrigation / aspiration (time) b. Reduced ultrasound phacoemulsification		Time of surgery	No
Primary	Posterior capsule rupture < 10% occurrence rate		Time of Surgery	Yes
Primary	Less than 5% of eyes should lose more than two lines of BSCVA		3 months post-operative	Yes