Trials Sponsors Conditions Drugs Pricing

Conditions

Refractive Astigmatism

Outcome Measures

Primary Outcomes (2)

Change in Refractive Astigmatism
Change in mean cylinder (assessed by manifest refraction) compared to baseline.
6 months
Change in Keratometric Cylinder
Change in mean keratometric cylinder (as measured by keratometry) compared to baseline.
6 Months

Study Arms (2)

Natural Astigmatism

EXPERIMENTAL

Subjects with refractive astigmatism and no prior history of ophthalmic surgery. May include subjects with cataracts.

Device: iFS™ Femtosecond Laser System

Post cataract with residual astigmatism

EXPERIMENTAL

Subjects who have had cataract removal surgery but have residual astigmatism.

Device: iFS™ Femtosecond Laser System

Interventions

iFS™ Femtosecond Laser SystemDevice

intrastromal arcuate cuts made with iFS™ femtosecond laser

Also known as: iFS™ is part of the product brand name - there is no expanded acronym

Natural AstigmatismPost cataract with residual astigmatism

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age21 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female, of any race, and at least 21 years of age at the time of the pre-operative examination and signing the consent form
Refractive error, no limitation on spherical refractive myopia or hyperopia and refractive astigmatism of 0.75 to 7.00 diopters (D) in the operative eye

Sponsors & Collaborators

Abbott Medical Optics
Industrylead

Study Sites (1)

Paracelsus Medizinische Privat-Universitat, PMU

Salzburg, State of Salzburg, 5020, Austria

Limitations and Caveats

This evaluation was performed on a small number of subjects and should be repeated in a larger number of subjects.

Results Point of Contact

Title: Carrie Garufis
Organization: AMO Development, LLC

Study Officials

Nicholas Tarantino, OD
Abbott Medical Optics
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

21 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 24, 2010

First Posted

September 29, 2010

Study Start

July 2010

Date type not reported

This date has not been verified as actual or estimated.

Feasibility of iFS™ for Intrastromal Arcuate Keratotomy (ISAK) Procedures

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Natural Astigmatism

Post cataract with residual astigmatism

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Natural Astigmatism

Post cataract with residual astigmatism

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations