Clinical trial NCT02072122: Estrogen and the Outer Eye in Women During Fertility Treatment
Official title: The Influence of the Hormonal Fertility Treatment of Women, on the Eye Surface and the Eye Dryness
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dry Eye Syndromes
Keywords: dry eye
fertility treatment
Meibomian gland dysfunction
supra physiologic estrogen level
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2014-02-26
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: fertility clinic patients

Brief summary: The purpose of this study is to determine the relation between estrogen and progesterone levels, and between dryness of the eyes, in women during their fertile years.

Detailed description: Women during their fertility treatments will be submitted to the research. The research will include 3 meetings with a doctor from the ophthalmology department. Each meeting will be individual for each participant of the research.

The meetings will take place during the day of regular appointment of the participant to the fertility clinic.

Meeting #1:

During first visit to the fertility clinic for the stimulation process.

During this day will be done:

1.Submission of the patient to the research and signing on letter of agreement 2.Blood tests for estrogen, progesterone, luteinizing hormone (LH) 3.Eye examination: 3a. Filling of Schein Questionnaire 3b. Examination of the external eye: 1.microscope, 2.Schirmer test (paper strips inserted into the eye for several minutes to measure the production of tears), 3. tear break up time test (checking the eye with the fluorescein light after painting the eye with fluorescein dye) 3c. Checking the Intra Ocular Pressure with Tonometer

Meeting #2:

During visit to the fertility clinic for the egg collection (about 10 days after meeting #1)

During this day will be done:

1.Blood tests for estrogen, progesterone, luteinizing hormone (LH) 2.Eye examination: 2a. Filling of Schein Questionnaire 2b. Examination of the external eye: 1.microscope, 2.Schirmer test (paper strips inserted into the eye for several minutes to measure the production of tears), 3. tear break up time test (checking the eye with the fluorescein light after painting the eye with fluorescein dye) 2c. Checking the Intra Ocular Pressure with Tonometer

Meeting #3:

During visit to the fertility clinic for the pregnancy test (about 14 days after meeting #2)

During this day will be done:

1. Blood tests for estrogen, progesterone, luteinizing hormone (LH)
2. Eye examination:

2a. Filling of Schein Questionnaire 2b. Examination of the external eye: 1.microscope, 2.Schirmer test (paper strips inserted into the eye for several minutes to measure the production of tears), 3. tear break up time test (checking the eye with the fluorescein light after painting the eye with fluorescein dye) 2c. Checking the Intra Ocular Pressure with Tonometer

Collection and summary of all the data End of the research

Eligibility criteria: Inclusion Criteria:

* women during fertility treatment
* without any known eye diseases
* no current or past history of treatment against dry eye

Exclusion Criteria:

* known eye disease
* current or past history of treatment against dry eye

Primary outcomes:
measure: Evidence of clinically definite dry eye confirmed by Schirmer test and tear break up time test
timeFrame: 24 days
Secondary outcomes:
measure: Evidence of clinically definite dry eye confirmed by Schirmer test and tear break up time test during each on of the meetings #1,#2 (day 0, day 10)
timeFrame: 0 days, 10 days
Other outcomes:
Locations:
Study officials:
References: