Hydration Status and Ocular Parameters Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAnte Kreso

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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).

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Relative DehydrationExperimental treatment 1 intervention
Group B: HyperhydrationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in macular thickness between dehydration and hyperhydration states

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.

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ante Kreso

Lead sponsor

University Hospital of Split

Sponsor institution

University Hospital of Split

Collaborator

University of Split, School of Medicine

Collaborator

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