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Laser Treatment of the Crystalline Lens

Primary Purpose

Cataract

Status

Unknown status

Phase

Phase 2

Locations

Mexico

Study Type

Interventional

Intervention

LensAR laser surgery

Phaco-emulsification cataract surgery

About this trial

This is an interventional treatment trial for Cataract focused on measuring Cataract, Capsulotomy, Capsulorrhexis, Phacoemulsification

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Asociacion Para Evitar La Cuguera en Mexico IAP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laser treated

Control Eye

Arm Description

Eye treated with LensAR Laser System

Contralateral eye treated with conventional phaco-emulsification

Outcomes

Primary Outcome Measures

Capsulotomy a. Ease of opening b. Achievement of intended shape and size

Lens removal a. Ease of irrigation / aspiration (time) b. Reduced ultrasound phacoemulsification

Posterior capsule rupture < 10% occurrence rate

Less than 5% of eyes should lose more than two lines of BSCVA

Secondary Outcome Measures

Full Information

NCT ID

NCT01001117

First Posted

October 22, 2009

Last Updated

April 14, 2011

Sponsor

LensAR Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT01001117

Brief Title

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

2. Study Status

Record Verification Date

April 2011

Overall Recruitment Status

Unknown status

Study Start Date

October 2008 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

April 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

LensAR Incorporated

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract

Keywords

Cataract, Capsulotomy, Capsulorrhexis, Phacoemulsification

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Laser treated

Arm Type

Experimental

Arm Description

Eye treated with LensAR Laser System

Arm Title

Control Eye

Arm Type

Active Comparator

Arm Description

Contralateral eye treated with conventional phaco-emulsification

Intervention Type

Device

Intervention Name(s)

LensAR laser surgery

Other Intervention Name(s)

LensAR Laser System

Intervention Description

Use of laser for cataract surgery

Intervention Type

Device

Intervention Name(s)

Phaco-emulsification cataract surgery

Other Intervention Name(s)

Exact equipment varies

Intervention Description

Phaco-emulsification cataract surgery

Primary Outcome Measure Information:

Title

Capsulotomy a. Ease of opening b. Achievement of intended shape and size

Time Frame

Time of Surgery

Title

Lens removal a. Ease of irrigation / aspiration (time) b. Reduced ultrasound phacoemulsification

Time Frame

Time of surgery

Title

Posterior capsule rupture < 10% occurrence rate

Time Frame

Time of Surgery

Title

Less than 5% of eyes should lose more than two lines of BSCVA

Time Frame

3 months post-operative

10. Eligibility

Sex

All

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ramon Naranjo, MD

Organizational Affiliation

Asociacion Para Evitar La Ceguera en Mexico IAP

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jorge VIllar, MD

Organizational Affiliation

Asociacion Para Evitar La Ceguera en Mexico IAP

Official's Role

Principal Investigator

Facility Information:

Facility Name

Asociacion Para Evitar La Cuguera en Mexico IAP

City

Mexico City

ZIP/Postal Code

DF 04030

Country

Mexico

12. IPD Sharing Statement

Citations:

PubMed Identifier

21397456

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.

Results Reference

derived

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Laser Treatment of the Crystalline Lens

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