NCT01001117

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2009

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

April 15, 2011

Status Verified

April 1, 2011

Enrollment Period

1 year

First QC Date

October 22, 2009

Last Update Submit

April 14, 2011

Conditions

Cataract

Keywords

CataractCapsulotomyCapsulorrhexisPhacoemulsification

Outcome Measures

Primary Outcomes (4)

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

    Time of Surgery

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

    Time of surgery

  • Posterior capsule rupture < 10% occurrence rate

    Time of Surgery

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

    3 months post-operative

Study Arms (2)

Laser treated

EXPERIMENTAL

Eye treated with LensAR Laser System

Device: LensAR laser surgery

Control Eye

ACTIVE COMPARATOR

Contralateral eye treated with conventional phaco-emulsification

Device: Phaco-emulsification cataract surgery

Interventions

LensAR laser surgeryDEVICE

Use of laser for cataract surgery

Also known as: LensAR Laser System
Laser treated
Phaco-emulsification cataract surgeryDEVICE

Phaco-emulsification cataract surgery

Also known as: Exact equipment varies
Control Eye

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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 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.

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asociacion Para Evitar La Cuguera en Mexico IAP

Mexico City, DF 04030, Mexico

Location

Related Publications (1)

  • 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.

    PMID: 21397456DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Ramon Naranjo, MD

    Asociacion Para Evitar La Ceguera en Mexico IAP

    PRINCIPAL INVESTIGATOR

  • Jorge VIllar, MD

    Asociacion Para Evitar La Ceguera en Mexico IAP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 22, 2009

First Posted

October 23, 2009

Study Start

October 1, 2008

Primary Completion

October 1, 2009

Study Completion

April 1, 2011

Last Updated

April 15, 2011

Record last verified: 2011-04

Locations

ME(1)