Retinal Nerve Fiber Layer and Macular Thickness Changes During Pregnancy

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02154945
• Other study ID #: 33-2013.CTIL
• Status: Withdrawn
• Phase: N/A
• First received: May 28, 2014
• Last updated: January 12, 2016
• Start date: January 2016
• Est. completion date: January 2016

Study information

• Verified date: June 2014
• Source: The Baruch Padeh Medical Center, Poriya
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 1st trimester (6-14w) pregnant healthy women

• 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:

• Retinal or optic nerve disease

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Macular Thickness
• Pregnancy
• Retinal Nerve Fiber Layer Thickness

Locations

Country	Name	City	State
Israel	Baruch Padeh Medical Center	Poriya	Lower Galeli

Sponsors (1)

Lead Sponsor	Collaborator
The Baruch Padeh Medical Center, Poriya

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal nerve fiber layer(RNFL) and Macular thickness by Optical coherence tomography(OCT) during pregnancy	The RNFL, measured in micrometers, will be followed up during the study. Every trimester (starting at the 1st trimester) an OCT will be performed measuring the thickness of the RNFL.; An OCT will be performed 3 months postpartum as a control.; The Macular thickness will be measured in the same manner.	1 year	Yes
Secondary	Effect of systemic and ocular diseases on Retinal Fiber Layer and Macula during pregnancy	If systemic or ocular diseases appear during the study, they will be followed up and observed for changes in retinal fiber layer thickness and macular thickness.	1 year	Yes