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Clinical Trials/NCT02072122
NCT02072122
Unknown
Not Applicable

The Influence of the Hormonal Fertility Treatment of Women, on the Eye Surface and the Eye Dryness

Meir Medical Center0 sites30 target enrollmentMarch 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dry Eye Syndromes
Sponsor
Meir Medical Center
Enrollment
30
Primary Endpoint
Evidence of clinically definite dry eye confirmed by Schirmer test and tear break up time test
Last Updated
12 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
March 2014
End Date
July 2014
Last Updated
12 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Evidence of clinically definite dry eye confirmed by Schirmer test and tear break up time test

Time Frame: 24 days

Secondary Outcomes

  • 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)(0 days, 10 days)

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