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NCT Number: NCT07177131

Hydration Status and Ocular Parameters Study

This study will examine how hydration status (drinking a large amount of water or avoiding water for a short period of time) affects the eye. Healthy adult volunteers will participate in two sessions: one after mild dehydration (no water for 12 hours) and one after drinking 2 liters of water within 4 hours. At each session, detailed eye measurements will be taken, including scans of the retina and optic nerve using optical coherence tomography (OCT), corneal imaging with Pentacam, and eye length measurements with an optical biometer. The results from the two conditions will be compared within the same participants.

The main goal is to determine whether hydration influences the thickness of the retina (macula). Secondary goals include assessing changes in the optic nerve, cornea, and other biometric eye parameters. The study involves only non-invasive tests and minimal risk. Findings may help improve understanding of how hydration affects the eye and may be important for clinical practice, such as planning cataract or refractive surgery.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adult volunteers aged 18 to 65 years
  • Normal ophthalmological findings
  • Best corrected visual acuity (BCVA) ≥ 1.0 (decimal)
  • Willingness to participate and provide written informed consent

Exclusion criteria

  • Known ocular diseases (e.g., glaucoma, keratoconus, retinal pathology)
  • History of ocular surgery
  • Systemic diseases affecting hydration status (e.g., diabetes mellitus, kidney disease)
  • Any condition that, in the investigator's opinion, could interfere with study participation or data quality
  • Refusal to participate

Treatment and study plan

Relative Dehydration Protocol

Behavioral

Participants will abstain from water intake for 12 hours prior to the study visit. Food is allowed, but fluid intake is limited to a maximum of 250 ml until 20:00 h on the previous evening. Eye measurements will be performed in the morning (8-10 h).

Hyperhydration Protocol

Behavioral

Participants will consume 2 liters of water within 4 hours prior to the study visit. Eye measurements will be performed in the morning (8-10 h).

Primary outcomes

  1. Change in macular thickness between dehydration and hyperhydration states

    Time frame: Within 1 week (cross-over design with ≥7-day washout period)

    Macular thickness (central subfield, parafoveal, and perifoveal regions) will be measured using Zeiss Cirrus HD-OCT. Each participant will undergo measurements in both hydration states, and paired comparisons will be performed.

Study contacts

Contact information is provided by the study sponsor or research team.

Ante Krešo, MD

CONTACT

[email protected]

+385 21 556 402

Sponsors and collaborators

Lead sponsor

Ante Kreso

Other

Collaborators

  • University Hospital of Split
  • University of Split, School of Medicine

Registry information

Official study title

Prospective, Randomized Cross-over Within-subject Study on the Effects of Dehydration and Hyperhydration on Macular Thickness, Corneal Morphology, and Ocular Biometric Parameters Measured by OCT, Pentacam and Optical Biometer

Acronym: HYDRI-EYE

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 16, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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