NCT02154945

Retinal Nerve Fiber Layer and Macular Thickness Changes During Pregnancy

Retinal Nerve Fiber Layer and Macular Thickness Changes During Pregnancy by Optical Coherence Tomography: Prospective, Observational, Nonrandomized Controlled Study

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: The Baruch Padeh Medical Center, Poriya · Other Government
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Purpose: 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.

Detailed description

There are several known ophthalmic physiologic changes in pregnancy: 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

• Pregnancy
• Retinal Nerve Fiber Layer Thickness
• Macular Thickness

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2014-06-04
• Last updated: 2016-01-13

Locations

1 site across 1 country: Israel