Corneal Biomechanical Properties in Pregnancy

NCT03500523 | Completed

• 1 other identifier: 11134
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Corneal Biomechanics; Pregnancy

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

1-study group

EXPERIMENTAL

study group: pregnant women

Diagnostic Test: corneal biomechanical properties

2-control group

EXPERIMENTAL

control group: healthy non pregnant women

Diagnostic Test: corneal biomechanical properties

Interventions

corneal biomechanical properties DIAGNOSTIC_TEST

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)

1-study group; 2-control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Funda Dikkaya

Istanbul, 34098, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 18, 2018
• Study Start: January 1, 2018
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: April 18, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)