Estrogen and the Outer Eye in Women During Fertility Treatment

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02072122
• Other study ID #: EOEDFT-2
• Status: Not yet recruiting
• Phase: N/A
• First received: February 24, 2014
• Last updated: February 25, 2014
• Start date: March 2014
• Est. completion date: July 2014

Study information

• Verified date: February 2014
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of clinically definite dry eye confirmed by Schirmer test and tear break up time test		24 days	No
Secondary	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	No