Corneal Sensation and Incidence of Dry Eye Post Refractive Cataract Extraction With FemtoSecond Laser

April 22, 2016 updated by: Ophthalmic Consultants of Long Island

A Post Market Pilot Study To Evaluate Corneal Sensation And The Incidence Of Dry Eye In Subjects Undergoing Refractive Cataract Extraction With The Femtosecond Laser For Arcuate Relaxing Incisions

The study objective is to assess changes in corneal sensation and dry eye signs and symptoms following cataract extraction/femtosecond arcuate relaxing incisions.

Our clinical hypothesis is to determine if a combination of cataract surgery and femtosecond arcuate relaxing incisions lead to a reduction in corneal sensation and the onset or worsening of dry eye signs and symptoms.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rockville Centre, New York, United States, 11570
        • Recruiting
        • Ophthlamic Consultants of Long Island - Rockville Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Private Practice

Description

Inclusion Criteria:

  • Male or female subjects 18 years or older, in good general health
  • Prior to signing the Institutional Review Board approved Informed Consent Form / Health Insurance Portability and Accountability Act subject read and gained an understanding of the contents
  • Subject scheduled for cataract extraction with intraocular lens and requiring two (2) femtosecond arcuate relaxing incisions for correction of corneal astigmatism
  • Subject has greater than or equal to 1.0 D and less than or equal to 2.5 Diopters of corneal astigmatism as measured by keratometry or corneal topography
  • Two (2) arcuate incisions should be 45° in length and 180° apart.
  • All arcuate relaxing incisions will be placed exactly 4.5 mm from the visual axis for a 9 mm optical zone.
  • Corneal sensation at Screening by Cochet-Bonnet Aesthesiometry with floor stand >50 mm in all five regions
  • Be willing / able to return for all required study visits and comply with instructions given by study staff
  • Potential for best corrected visual acuity post cataract surgery of 20/20

Exclusion Criteria:

  • Uncontrolled inflammation not related to dry eye
  • Corneal abnormality that can affect corneal sensation or tear film stability (except superficial punctate keratitis (SPK)).
  • History of ophthalmic herpes simplex or zoster keratitis
  • OSDI score > 32
  • Active ocular allergy
  • History of refractive surgery or any surgery involving conjunctival, arcuate or corneal incision
  • Contact lens wear during the study. Soft contact lens wearers should discontinue use at least two weeks prior to Screening visit. Rigid gas permeable (RGP) or hard contact lens wearers should discontinue use at least one month prior to Screening visit.
  • Dry eye secondary to Vitamin A deficiency, scarring, pemphigoid, alkali burns, Stevens-Johnson syndrome, trachoma, or irradiation.
  • Currently using, or have used within 14 days of study enrollment, any ocular medications other than artificial tears
  • Use of topical cyclosporine (Restasis) within three months of Screening visit.
  • Have an uncontrolled systemic disease (e.g., hypertension, diabetes) or the presence of any significant illness (e.g., serious gastrointestinal, renal, hepatic, endocrine, pulmonary, cardiac, neurological disease, cancer, AIDS, or cerebral dysfunction) that could, in the judgment of the investigator, jeopardize subject safety or interfere with the interpretation of the results of the study
  • Temporary or permanent occlusion of the lacrimal puncta
  • Require chronic use of systemic medications which may induce or affect a dry eye condition (e.g., anticholinergics, cyclosporine, antihistamines, antimuscarinics, beta-blocking agents, tricyclic antidepressants, phenothiazines, estrogen-progesterone, and other estrogen derivatives), unless that medication has been used in the same dose for at least 3 months and is expected to remain constant for the course of the study
  • Current or anticipated use of nutritional supplements (e.g. flax seed oil, fish oil, omega-3 supplements) which may affect a dry eye condition.
  • Are currently enrolled in any other clinical study or have participated in such a study within 30 days of entry into this study
  • Is pregnant, breast-feeding, planning a pregnancy, or not using a reliable method of contraception. Subjects who become pregnant during the study will be discontinued from further study participation.
  • Have a condition or are in a situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with their participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Corneal Sensitivity Testing
Time Frame: Change from Screening to Month 3
Subject lies supine with the test line of the Cochet-Bonnet Aesthesiometer suspended over the cornea to measure the sensation of touch on the eye. Testing is done in a standard manner by an experienced operator.
Change from Screening to Month 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ocular Surface Disease Index (OSDI)
Time Frame: Change from Screening to Month 3
Subject questionnaire
Change from Screening to Month 3
Subject Dry Eye Questionnaire
Time Frame: Change from Screening to Month 3
Subject questionnaire
Change from Screening to Month 3
Artificial Tear Use
Time Frame: Change from Screening to Month 3
Subject questionnaire
Change from Screening to Month 3
Corneal and Conjunctival Staining
Time Frame: Change from Screening to Month 3
Clinical assessment of Dry Eye severity on the cornea via the use of fluorescein dye and on the conjunctiva via the use of lissamine green dye.
Change from Screening to Month 3
Tear Break Up Time (TBUT) with Biomicroscopy
Time Frame: Change from Screening to Month 3
Clinical assessment of Dry Eye severity via Biomicroscopy with fluorescein dye
Change from Screening to Month 3
Best Corrected Visual Acuity (BCVA)
Time Frame: Change from Screening to Month 3
Best Corrected Visual Acuity via eye chart examination
Change from Screening to Month 3
Intraocular Pressure (IOP)
Time Frame: Change from Screening to Month 3
Intraocular pressure via slit lamp examination
Change from Screening to Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ophthalmic Consultants of Long Island

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2011

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AGN02-FEMTO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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