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CompletedNCT03500523Updated Apr 18, 2018

Corneal Biomechanical Properties in Pregnancy

An interventional study of corneal biomechanical properties in Corneal Biomechanics and Pregnancy, sponsored by Medipol University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-18.

Sponsored by Medipol University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jan 2018, registered Apr 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
83
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

57 eyes of 57 healthy pregnant women who were visiting Obstetrics and Gynecology department for routine examination and 26 eyes of 26 non pregnant control subjects who were at the first week of the menstrual cycle were enrolled in the study. All subjects had a detailed ophthalmologic examination including the best corrected visual acuity with a Snellen chart, slit- lamp biomicroscopic evaluation, and indirect fundoscopy. The biomechanical properties Corneal Hysteresis, Corneal resistance factor, corneal compensated intraocular pressure and Goldmann-correlated intraocular pressure values were measured with ORA (Ocular Response Analyzer, software version 1.02, Reichert, Inc.) Central corneal thickness was measured with a built-in ultrasonic pachymeter attached to the ORA device.Axial length , Anterior chamber depth , and keratometry readings were acquired with an ocular biometer (IOLMaster; Carl-Zeiss Meditec, Inc.) before CCT determinations had been taken. Results of these parameters were compared between pregnant group and healthy control group.

02

Conditions studied

  • Corneal Biomechanics
  • Pregnancy
03

In context

Lead sponsor

Medipol University is the lead sponsor of 311 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 57 eyes of 57 healthy pregnant women who were visiting Obstetrics and Gynecology department for routine examination and 26 eyes of 26 non pregnant control subjects who were at the first week of the menstrual cycle were included in the study.

Exclusion criteria

Exclusion Criteria:

  • Exclusion criteria included history of intraocular surgery or refractive surgery, history of glaucoma or glaucoma suspicion, contact lens wear, systemic autoimmune disease or diabetes and usage of eye drop and oral contraceptives.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
83 participants (actual)

Study arms

  • Experimental
    1-study group

    study group: pregnant women

    Diagnostic Test: corneal biomechanical properties

  • Experimental
    2-control group

    control group: healthy non pregnant women

    Diagnostic Test: corneal biomechanical properties

Interventions

  • Diagnostic testcorneal biomechanical properties

    We want to investigate changes of corneal biomechanical properties during pregnancy. The Ocular Response Analyzer (ORA) evaluate the in vivo corneal biomechanical properties in form of corneal hysteresis (CH) and corneal resistance factor (CRF)

06

What researchers measure

Primary outcomes

  1. changes of corneal hysteresis during pregnancy

    we analyzed the biomechanical properties of the cornea in terms of corneal hysteresis (mmHg) by using ocular response analyzer device in healthy pregnant women and compared the data with non pregnant women.

    Time frame: three months

  2. changes of corneal resistance factor during pregnancy

    we analyzed the biomechanical properties of the cornea in terms of corneal resistance factor (mmHg) by using ocular response analyzer device in healthy pregnant women and compared the data with non pregnant women.

    Time frame: three months

07

Study locations

1 site
  • Funda Dikkaya
    Istanbul, 34098, Turkey
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03500523
Lead sponsor
Medipol University
Responsible party
Funda Dikkaya (principal investigator, Medipol University) — Principal investigator
First posted
Apr 18, 2018
Start date
Jan 1, 2018
Primary completion
Mar 31, 2018
Completion
Mar 31, 2018
Last update
Apr 18, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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