Corneal Biomechanical Properties in Pregnancy

Pregnancy Clinical Trial

Official title:

Corneal Biomechanical Properties in Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03500523
• Other study ID #: 11134
• Status: Completed
• Phase: N/A
• First received: April 3, 2018
• Last updated: April 9, 2018
• Start date: January 1, 2018
• Est. completion date: March 31, 2018

Study information

• Verified date: April 2018
• Source: Medipol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 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.

Related Conditions & MeSH terms

• Corneal Biomechanics
• Pregnancy

Intervention

Diagnostic Test:
• corneal 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)

Locations

Country	Name	City	State
Turkey	Funda Dikkaya	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	three months
Primary	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.	three months