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Non-invasive Tear Film Dynamic Measurements in Normal, MGD and ADDE Subjects After Saline Instillation

Not Applicable
Completed
Conditions
Meibomium Gland Dysfunction
Aqueous Deficient Dry Eye
Interventions
Behavioral: Subjective Questionnaire
Procedure: Measurement with wavefront sensor (right eye, then left eye)
Drug: Instill Saline Drop
Registration Number
NCT01128049
Lead Sponsor
University of Rochester
Brief Summary

Compare the objective tear film dynamic measurements in three different populations (MGD \[Meibomium Gland Dysfunction\], ADDE \[Aqueous Deficient Dry Eye\] and normal/control \[non-dry eye\]) and the subjective experience before and after instilling a single drop of saline in each eye.

Currently available office-based tests for dry eye do not reliably correlate with patients' subjective symptoms. This study is interested in assessing how individuals with these two different ocular surface diseases compare with the normal population when measured objectively using two different instruments.

Detailed Description

There will be one study day with a single visit that will consist of taking two sets of measurements. Baseline measurements are taken in both eyes using a wavefront sensor to measure visual quality followed by saline instillation. Five minutes after drops, visual quality is again measured to evaluate changes in tear dynamics.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
15
Inclusion Criteria
  • Good general Health
  • The subject must appear able and willing to adhere to the instructions set forth in this protocol (such as not use warm compresses or artificial tears/lubricant or excessive eye makeup before the visit on the study day).

General

Exclusion Criteria
  • Ocular disease, infection or inflammation (allergy, blepharitis) that is clinically significant (grade 3 or 4) that in the opinion of the PI would not be a good subject.
  • Systemic disease or use of medication that in the opinion of the PI would not be a good subject.
  • Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
  • Contact lens wearer.
  • Pregnancy or lactation.
  • Diabetes.
  • Inclusion or exclusion criteria of the other cohorts.

Cohort Specific Inclusion Criteria:

  • ADDE cohort: Schirmer I < 10 mm, BUT ¬< 5 seconds, Fluorescein 0 or 1, currently using an artificial tear for ocular comfort at least occasionally.
  • MGD cohort: Diagnosis of moderate or severe MGD
  • Normal/Control (Non Dry-Eye): meets general inclusion and exclusion criteria

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ADDE PopulationInstill Saline DropAqueous Deficient Dry Eye population(intervention remains the same across all arms)
ADDE PopulationSubjective QuestionnaireAqueous Deficient Dry Eye population(intervention remains the same across all arms)
MGD Patient PopulationInstill Saline DropMeibomium Gland Dysfunction population(intervention remains the same across all arms)
Normal Patient PopulationSubjective QuestionnaireNon-Dry Eye patient population (intervention remains the same across all arms)
Normal Patient PopulationMeasurement with wavefront sensor (right eye, then left eye)Non-Dry Eye patient population (intervention remains the same across all arms)
Normal Patient PopulationInstill Saline DropNon-Dry Eye patient population (intervention remains the same across all arms)
MGD Patient PopulationSubjective QuestionnaireMeibomium Gland Dysfunction population(intervention remains the same across all arms)
MGD Patient PopulationMeasurement with wavefront sensor (right eye, then left eye)Meibomium Gland Dysfunction population(intervention remains the same across all arms)
ADDE PopulationMeasurement with wavefront sensor (right eye, then left eye)Aqueous Deficient Dry Eye population(intervention remains the same across all arms)
Primary Outcome Measures
NameTimeMethod
Visual Quality5 seconds

Average visual quality change over a 5 second blink cycle caused by movement of the tears over the surface of the eye by measuring optical irregularities.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

The Flaum Eye Institute-University of Rochester

🇺🇸

Rochester, New York, United States

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