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Search / Trial NCT04773574

Physiologic Ocular Changes During Pregnancy in Women With High Myopia.

Launched by KHON KAEN UNIVERSITY · Feb 25, 2021

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

High Myopia Pregnancy Choroidal Thickness Retinal Vascular Density Retinal Nerve Fiber Layer Thickness Corneal Curvature

ClinConnect Summary

This clinical trial is studying how pregnancy affects the eyes of women with high myopia, which is a condition where the eyeball is longer than normal, leading to blurry vision and an increased risk of serious eye problems. The researchers are particularly interested in understanding any changes that occur in the eyes during pregnancy, as normal labor can sometimes lead to complications for these women. The goal is to gather information that could help develop better care guidelines for pregnant women with high myopia.

To participate in this study, women must be over 18 years old, have high myopia (defined as having a specific level of nearsightedness), and be pregnant with one baby. They should also have clear vision without any serious eye conditions. Participants will be monitored throughout their pregnancy to track any changes in their eye health. It’s important to note that women with certain health issues or previous eye surgeries may not be eligible. This trial aims to improve the understanding of eye health in pregnant women with high myopia, which could ultimately lead to better safety measures during childbirth.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • age \> 18 years
  • high myopia: spherical equivalent \> 6 diopters and/or axial length \> 26.5 mm
  • singleton pregnancy
  • clear ocular media
  • written inform consent
  • Exclusion Criteria:
  • high risk pregnancy such as pre-eclampsia, gestational diabetes mellitus, hyperthyroidism and asthma.
  • history of retinal diseases such as macular edema and retinal vascular occlusion
  • history of intraocular inflammation or endophthalmitis
  • history of intraocular laser treatment
  • history of intraocular surgery
  • Withdrawal criteria
  • childbirth before 34 weeks' gestation
  • multifetal pregnancy was detected by ultrasound
  • high risk pregnancy which could not follow the research protocol such as severe pre-eclampsia
  • retinal diseases occur during the follow-up period such as central serous chorioretinopathy, retinal detachment and choroidal neovascularization
  • significant ocular trauma during the follow-up period
  • severe peripartum or postpartum complications such as thromboembolic disease and postpartum hemorrhage

About Khon Kaen University

Khon Kaen University is a leading research institution in Thailand, dedicated to advancing medical science and improving healthcare outcomes through innovative clinical trials. With a commitment to ethical research practices and community health, the university collaborates with various national and international partners to conduct studies across diverse fields, including public health, pharmaceuticals, and medical devices. By leveraging its multidisciplinary expertise and state-of-the-art facilities, Khon Kaen University aims to contribute valuable insights and evidence-based solutions that address pressing health challenges both locally and globally.

Locations

Patients applied

0 patients applied

Trial Officials

Suthasinee Sinawat, MD

Principal Investigator

KKU Eye Center, Department of Ophthalmology, Faculty of Medicine, Khon Kaen University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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