PregnancyNCT02154945
Retinal Nerve Fiber Layer and Macular Thickness Changes During Pregnancy
An observational study of Pregnancy and Retinal Nerve Fiber Layer Thickness, run by The Baruch Padeh Medical Center, Poriya at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Retinal Nerve Fiber Layer Thickness, Macular Thickness
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2016to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
Baruch Padeh Medical Center
Poria – Neve Oved, Lower Galeli, 15208
About this study
Official title: 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.
Read the detailed description
There are several known ophthalmic physiologic changes in pregnancy:
- 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
- Night vision decreased mainly with low serum vitamin A levels in pregnant women.
- Fall of the IOP in second half of pregnancy (about 10% drop)
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study startJan 2016
- Primary completionJan 2016 (estimated)
- Study completionJan 2016
Why it stopped: Did not go through with the study for logistical reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Baruch Padeh Medical Center, Poriya
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nakhoul Fa Nakhoul, MD, Principal investigator, Baruch Padeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154945
- Sponsor's protocol ID
- 33-2013.CTIL
- Status last verified
- Jun 2014
- First submitted
- 28 May 2014
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Nerve Fiber Layer and Macular Thickness Changes During Pregnancy by Optical Coherence Tomography: Prospective, Observational, Nonrandomized Controlled Study
- ClinicalTrials.gov ID
- NCT02154945
- Acronym / sponsor ID
- 33-2013.CTIL
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Did not go through with the study for logistical reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Baruch Padeh Medical Center, PoriyaOther government
- Study start
- Jan 2016
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (actual)
- First posted
- 4 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Night vision decreased mainly with low serum vitamin A levels in pregnant women.
- Fall of the IOP in second half of pregnancy (about 10% drop)
- 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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant patients
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retinal nerve fiber layer(RNFL) and Macular thickness by Optical coherence tomography(OCT) during pregnancy
Time frame: 1 year
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 secondary outcome
Effect of systemic and ocular diseases on Retinal Fiber Layer and Macula during pregnancy
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nakhoul Fa Nakhoul, MD principal investigator
Baruch Padeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Retinal Nerve Fiber Layer Thickness, run by The Baruch Padeh Medical Center, Poriya at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal nerve fiber layer(RNFL) and Macular thickness by Optical coherence tomography(OCT) during pregnancy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2016.