Clinical trial NCT01001117: Laser Treatment of the Crystalline Lens
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Cataract
Keywords: Cataract
Capsulotomy
Capsulorrhexis
Phacoemulsification
Lead sponsor: LensAR Incorporated
Sponsor class: INDUSTRY
First posted: 2009-10-23
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The use of a femtosecond laser in cataract surgery that gives equivalent or improved results comapred to conventional phaco-emulsification surgery.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Capsulotomy a. Ease of opening b. Achievement of intended shape and size
timeFrame: Time of Surgery
measure: Lens removal a. Ease of irrigation / aspiration (time) b. Reduced ultrasound phacoemulsification
timeFrame: Time of surgery
measure: Posterior capsule rupture < 10% occurrence rate
timeFrame: Time of Surgery
measure: Less than 5% of eyes should lose more than two lines of BSCVA
timeFrame: 3 months post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Asociacion Para Evitar La Cuguera en Mexico IAP
Study officials:
affiliation: Asociacion Para Evitar La Ceguera en Mexico IAP
name: Ramon Naranjo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asociacion Para Evitar La Ceguera en Mexico IAP
name: Jorge VIllar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tackman RN, Kuri JV, Nichamin LD, Edwards K. Anterior capsulotomy with an ultrashort-pulse laser. J Cataract Refract Surg. 2011 May;37(5):819-24. doi: 10.1016/j.jcrs.2010.11.030. Epub 2011 Mar 11.