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CataractNCT01441895

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

An observational study of Cataract and Dry Eye, run by Ophthalmic Consultants of Long Island at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cataract, Dry Eye
How many people
40 participants
Where
1 siteUnited States
Study dates
Sep 2011to Dec 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Private Practice

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site, 1 recruiting

  • Ophthlamic Consultants of Long Island - Rockville Centre

    Rockville Centre, New York, 11570

    Joan Fredrickson, 516-705-7140, jfredrickson@ocli.net

    Recruiting

Other trials in United States

About this study

Official title: 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.

Conditions
Cataract, Dry Eye
Keywords
Refractive Cataract Extraction, Femtosecond laser, arcuate relaxing incisions, Dry Eye post cataract refraction
Medical subject headings
Cataract, Dry Eye Syndromes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Corneal Sensitivity Testing

    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.

    Measured: Change from Screening to Month 3

Secondary outcomes (7)

  1. Ocular Surface Disease Index (OSDI)

    Subject questionnaire

    Measured: Change from Screening to Month 3

  2. Subject Dry Eye Questionnaire

    Subject questionnaire

    Measured: Change from Screening to Month 3

  3. Artificial Tear Use

    Subject questionnaire

    Measured: Change from Screening to Month 3

  4. Corneal and Conjunctival Staining

    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.

    Measured: Change from Screening to Month 3

  5. Tear Break Up Time (TBUT) with Biomicroscopy

    Clinical assessment of Dry Eye severity via Biomicroscopy with fluorescein dye

    Measured: Change from Screening to Month 3

  6. Best Corrected Visual Acuity (BCVA)

    Best Corrected Visual Acuity via eye chart examination

    Measured: Change from Screening to Month 3

  7. Intraocular Pressure (IOP)

    Intraocular pressure via slit lamp examination

    Measured: Change from Screening to Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionDec 2016 (estimated)
  4. Study completionDec 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01441895
Sponsor's protocol ID
AGN02-FEMTO
Status last verified
Apr 2016
First submitted
21 Sep 2011
Last updated
25 Apr 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cataract and Dry Eye, run by Ophthalmic Consultants of Long Island at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Corneal Sensitivity Testing (time frame: Change from Screening to Month 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01441895.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2016.

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