The Water Drinking Test in Glaucoma Study

NCT05283031 | Completed Results

• 1 other identifier: 19IC5525
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the correlation and agreement between the intraocular pressure peaks detected during the water drinking test and modified diurnal tension curve in glaucomatous eyes and to analyse whether this is associated with prognostic outcome. The study will also measure autonomic nervous system activation during the test to investigate one possible mechanism behind it.

Conditions

Glaucoma

Keywords

Intraocular Pressure; Stress Test; Correlation; Water Drinking Test; OCT; Normal Tension Glaucoma

Outcome Measures

Primary Outcomes (1)

• Maximum Intraocular Pressure Difference (Between mDCT and WDT)

  Maximum intraocular pressure difference between two methods applied to each subject (modified diurnal tension curve mDTC and water drinking test WDT). The difference between maximum intraocular pressure of five eye pressure measurements taken at 8:00, 10:00, 12:00, 14:00 and 16:00 minus the maximum intraocular pressure measured at 15 minute intervals over 45 minutes during the water drinking test.

  Single measurement (mDCT 5 measurements taken one every 2 hours and WDT a measurement taken every 15 minutes up to 45 minutes)

Interventions

Modified Diurnal Tension Curve DIAGNOSTIC_TEST

The modified diurnal tension curve (mDTC), an alternative that involves IOP measurements every 2 or 3 hours during office hours, is more feasible and may provide better information regarding the IOP profile than single IOP measurements.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary open-angle and normal tension glaucoma patients

You may qualify if:

• Able to give informed consent to participate in the study
• Aged between 18 and 80 years of age
• Clear optical media
• Spherical equivalent +-10 Dioptres
• Normal tension glaucoma proven by visual field testing or OCT imaging combined with clinical assessment.
• Primary open angle glaucoma proven by visual field testing or OCT imaging combined with clinical assessment.

You may not qualify if:

• Are using ocular hypotensive therapy, or have done so in the last 30 days
• Have any other known ocular disease (except glaucoma)
• Have serious cardiac or kidney disease (WDT contra-indication)
• Have swallowing difficulties associated with either a neurological or gastrointestinal condition.
• Patients with any contra-indication of drinking large amounts of water in a small period of time e.g. swallowing impairment, oesophageal stricture, gastric banding.
• Have secondary or narrow/closed angle glaucoma
• Patients submitted to any surgical procedure or laser intervention during the evaluation period

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College Ophthalmic Research Group

London, NW1 5QH, United Kingdom

Location

Related Publications (1)

• Yap TE, Gao Y, Ahmad H, Susanna F, Susanna R, Normando EM, Bloom PA, Cordeiro MF. Comparison of intraocular pressure profiles during the water drinking test and the modified diurnal tension curve. Eye (Lond). 2024 Jun;38(8):1567-1574. doi: 10.1038/s41433-024-02954-0. Epub 2024 Mar 7.

  PMID: 38454171 RESULT

MeSH Terms

Conditions

Glaucoma; Low Tension Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Optic Nerve Diseases

Results Point of Contact

• Title: Jamie Spofforth
• Organization: Imperial College Ophthalmology Research Group

Jamiespofforth@nhs.net

020 3312 6666

Study Officials

• Francesca Cordeiro

  Imperial College Healthcare NHS Trust

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 16, 2022
• Study Start: March 17, 2021
• Primary Completion: June 9, 2021
• Study Completion: June 9, 2021
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)