Retinal Nerve Fiber Layer and Macular Thickness Changes During Pregnancy
NCT ID: NCT02154945
Last Updated: 2016-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2016-01-31
2016-01-31
Brief Summary
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Primary: to prospectively measure Retinal Nerve Fiber Layer (RNFL) and macular thickness changes during pregnancy by Optical coherence tomography
Secondary: The effect of pregnancy abnormalities on RNFL and macular thickness in participants who develop systemic or ocular complications during the study period.
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Detailed Description
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1. Refractive Change: progesterone-mediated changes in fluid content partially accounts for refractive change of lens and cornea; myopic shift of less than 1 D was observed in in 15% of participating pregnant women
2. Night vision decreased mainly with low serum vitamin A levels in pregnant women.
3. Fall of the IOP in second half of pregnancy (about 10% drop)
4. Corneal changes (increased thickness; decreased sensitivity) = contact lens intolerance
The retina and optic nerve are considered part of central nervous system, the retina and choroid are highly vascularized. Due to changes in CSF and brain volume, vascular and fluid changes all over the pregnant woman's body we expect to find changes in RNFL and macular thickness during pregnancy.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* No known medical problems related to their current pregnancy on recruitment
* Age 18-45yrs
* No known retinal or optic nerve disease
* Refraction between +3.0 and -4.0 diopters
* Agrees to participate in the study
Exclusion Criteria
* Refractive errors more than +3.0 and -4.0.
* If already finished 14w gestation when recruited to the 1st OCT examination
* Known to have HTN or DM before gestation
* Ocular media abnormality that obscures OCT view or examination
18 Years
45 Years
FEMALE
Yes
Sponsors
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The Baruch Padeh Medical Center, Poriya
OTHER_GOV
Responsible Party
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Principal Investigators
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Nakhoul Fa Nakhoul, MD
Role: PRINCIPAL_INVESTIGATOR
Baruch Padeh Medical Center
Locations
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Baruch Padeh Medical Center
Poria – Neve Oved, Lower Galeli, Israel
Countries
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Other Identifiers
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33-2013.CTIL
Identifier Type: -
Identifier Source: org_study_id
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