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

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.

Study Overview

• Status: Withdrawn
• Conditions: Pregnancy; Retinal Nerve Fiber Layer Thickness; Macular Thickness

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• Israel
  • Lower Galeli
    • Poriya, Lower Galeli, Israel, 15208
      • Baruch Padeh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Pregnant patients

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The Baruch Padeh Medical Center, Poriya
• Investigators: Principal Investigator: Nakhoul Fa Nakhoul, MD, Baruch Padeh Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: May 28, 2014
• First Submitted That Met QC Criteria: June 1, 2014
• First Posted (Estimate): June 4, 2014

Study Record Updates

• Last Update Posted (Estimate): January 13, 2016
• Last Update Submitted That Met QC Criteria: January 12, 2016
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 33-2013.CTIL