NCT01713660

Brief Summary

The IntraLase iFS femtosecond laser system can create corneal arcuate incisions for cataract surgery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2012

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2012

Completed
7 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
5 months until next milestone

Results Posted

Study results publicly available

May 29, 2013

Completed
Last Updated

February 4, 2025

Status Verified

January 1, 2025

Enrollment Period

1 month

First QC Date

October 22, 2012

Results QC Date

April 5, 2013

Last Update Submit

January 31, 2025

Conditions

Cataract

Keywords

Cataract surgeryFemtosecond laserCorneal incisions

Outcome Measures

Primary Outcomes (1)

  • Demonstration That the Femtosecond Laser Consistently Produces Desired Incisions.

    Evaluation of incisions created as programmed and measurement in mm. Data reported will be based on intended incision size (as programmed) vs. achieved incision size (as measured).

    Day 0, Operative (Within 2 hours of incision creation)

Secondary Outcomes (2)

  • Surgeon Assessment of Workflow

    Day 0, Operative

  • Percent of Seidel Staining

    Day 0 (performed immediately post-incision creation), Day 1

Study Arms (1)

FS Corneal Incisions

OTHER
Device: iFS Femtosecond Laser

Interventions

iFS Femtosecond LaserDEVICE

corneal incisions created by the femtosecond laser

FS Corneal Incisions

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 21 years of age
  • Unilateral or bilateral cataract(s) for which phacoemulsification lens extraction and posterior chamber intraocular lens (IOL) implantation has been planned
  • Visual potential of 20/25 or better in each study eye following cataract removal and IOL implantation
  • Clear intraocular media other than cataract
  • Available, willing and capable of complying with examination procedures and follow-up visits for the duration of the study
  • Signed informed consent

You may not qualify if:

  • Previous intraocular or corneal surgery, including refractive surgery in the operative eye(s)
  • History of active or recurrent ophthalmic disease
  • Abnormal topography, including evidence of keratoconus or pellucid marginal degeneration or irregular astigmatism in the operative eye(s)
  • White to white measurement less than 10 mm or greater than 14 mm
  • Corneal pathology/abnormality that may interfere with the transmission of laser energy, laser light or precludes applanation
  • Corneal pathology/abnormality that is predicted to cause visual acuity losses to a level of 20/30 (Snellen) or worse during the study
  • Subjects with diagnosed degenerative visual disorders (e.g., macular or other retinal pathology) that are predicted to cause visual acuity losses to a level of 20/30 (Snellen) or worse during the study
  • Subjects with conditions associated with increased risk of IOL/capsule instability
  • Pharmacologically dilated pupil size less than 5.5 mm or the presence of any pupil abnormalities
  • Prior, current, or anticipated use during the course of the study of tamsulosin, silodosin or pilocarpine (e.g. Flomax, Flomaxtra, Rapaflo)
  • History of any ocular or medical conditions that could affect corneal wound healing
  • Poorly-controlled diabetes or subjects with diabetic retinopathy
  • Concurrent use of topical or systemic medications that may impair corneal wound healing
  • Acute, chronic, or uncontrolled systemic or ocular disease or illness that would, in the opinion of the investigator, increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, etc.)
  • Ocular hypertension (\> 21 mm Hg)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Results Point of Contact

Title
Carrie Garufis
Organization
AMO
carrie.garufis@amo.abbott.com
7145663728

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2012

First Posted

October 25, 2012

Study Start

November 1, 2012

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

February 4, 2025

Results First Posted

May 29, 2013

Record last verified: 2025-01