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Acute Ocular Hypertension GlaucomaNCT07495449

Effect of Infusion Warming on Mannitol Infusion Pain in Patients With Acute Ocular Hypertension

A study testing Infusion Warming Device and Routine Non-Warmed Mannitol Infusion in people with Acute Ocular Hypertension Glaucoma and Intraocular Hypertension, run by Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Acute ocular hypertension is a common ophthalmic emergency that often requires rapid reduction of intraocular pressure. Intravenous mannitol is widely used for this purpose, but infusion-related pain and local venous irritation may reduce patient comfort, interfere with infusion speed, and affect treatment experience. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Infusion Warming Device and Routine Non-Warmed Mannitol Infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
1 siteChina
Study dates
9 Jan 2025to 27 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with acute ocular hypertension requiring intravenous mannitol treatment in the ophthalmology setting
  • Age 18 years or older
  • Conscious and able to communicate pain and comfort during infusion
  • Able to provide informed consent personally or via a legally authorized representative when appropriate
  • Able to complete study-related assessments during and shortly after mannitol infusion

Who cannot join

  • Patients who did not require intravenous mannitol treatment
  • Known contraindication to intravenous mannitol treatment according to routine clinical practice
  • Patients receiving infusion of heat-sensitive fluids or medications for which infusion warming was not appropriate
  • Severe cognitive impairment, communication difficulty, or other conditions preventing reliable assessment of pain or comfort
  • Failure to complete key study outcome assessments
  • Refusal to participate in the study

Trial locations and contacts

1 site in 1 country.

China1 site
  • Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong

    Shantou, Guangdong, 515041

Other trials in China

About this study

Official title: Effect of Intravenous Infusion Warming on Pain, Comfort, Phlebitis, and Intraocular Pressure Outcomes During Mannitol Infusion in Patients With Acute Ocular Hypertension: A Randomized Controlled Study

Acute ocular hypertension is a common ophthalmic emergency that often requires rapid reduction of intraocular pressure. Intravenous mannitol is widely used for this purpose, but infusion-related pain and local venous irritation may reduce patient comfort, interfere with infusion speed, and affect treatment experience. This randomized controlled study aims to evaluate whether use of an infusion warming device during intravenous mannitol administration can reduce infusion-related pain, improve patient comfort, decrease local infusion-related complications, and improve infusion efficiency and short-term intraocular pressure outcomes in patients with acute ocular hypertension.

Participants with acute ocular hypertension who required intravenous mannitol treatment were randomly assigned to either a warming group or a non-warming group. In the warming group, mannitol was administered using an infusion warming device; in the non-warming group, mannitol was administered according to routine practice without warming. Outcomes included peak pain score during infusion, comfort score, infusion rate, infusion duration, local infusion-related adverse reactions, and intraocular pressure change after treatment.

Read the detailed description

Acute ocular hypertension requires timely reduction of intraocular pressure to relieve symptoms and reduce the risk of optic nerve damage. Intravenous mannitol is commonly used in ophthalmic emergency care because of its rapid osmotic effect. However, mannitol infusion may cause infusion-related pain, discomfort, slowing or interruption of infusion, and local venous complications such as irritation and phlebitis. These problems may affect both patient experience and treatment efficiency.

Warming of intravenous fluids has been used in clinical practice to reduce discomfort associated with infusion of hyperosmotic or irritating solutions. In this study, an infusion warming device was applied during intravenous mannitol administration to examine whether warming could improve the tolerability and clinical performance of mannitol infusion in patients with acute ocular hypertension.

Eligible patients requiring intravenous mannitol treatment were assigned to either a warming group or a non-warming group. In the warming group, mannitol was administered through an infusion warming device according to the study protocol. In the non-warming group, mannitol was infused without warming according to routine clinical practice. Patient-reported outcomes and clinical outcomes were assessed during and shortly after infusion.

The main objective of the study was to compare infusion-related pain between the two groups. Additional objectives were to compare comfort, infusion efficiency, local infusion-related complications, and short-term intraocular pressure response after treatment. The study was conducted at a tertiary ophthalmic center in China.

Being tested
Infusion Warming Device, Routine Non-Warmed Mannitol Infusion
Keywords
Mannitol Infusion Warming, Intravenous Infusion, Infusion Pain, Intraocular Pressure, Ocular Hypertension, Ophthalmic Nursing
Medical subject headings
Glaucoma, Angle-Closure, Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Infusion Warming DeviceDevice

    An infusion warming device was used during intravenous mannitol administration to warm the infused fluid according to the study protocol.

  • Routine Non-Warmed Mannitol InfusionOther

    Intravenous mannitol was administered according to routine clinical practice without infusion warming.

Study groups in NCT07495449
Study groupRoleWhat they receive
Warming GroupExperimentalParticipants received intravenous mannitol infusion using an infusion warming device during treatment for acute ocular hypertension.
Receives: Device: Infusion Warming Device
Non-Warming GroupActive comparatorParticipants received routine intravenous mannitol infusion without use of an infusion warming device during treatment for acute ocular hypertension.
Receives: Other: Routine Non-Warmed Mannitol Infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peak pain score during infusion measured by the 11-point Numeric Rating Scale (NRS)

    Peak infusion-related pain during intravenous mannitol administration, assessed using the 11-point Numeric Rating Scale (NRS). Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain.

    Measured: During infusion, up to approximately 45 minutes

Secondary outcomes (9)
  1. Comfort during infusion measured by a 10-point Visual Analogue Scale (VAS)

    Patient-reported comfort during intravenous mannitol administration, assessed using a 10-point Visual Analogue Scale (VAS). Scores range from 0 to 10, where 0 indicates the lowest comfort and 10 indicates the highest comfort. Higher scores indicate better comfort.

    Measured: During infusion, up to approximately 45 minutes

  2. Maximum infusion rate (drops/minute)

    Maximum achievable intravenous infusion rate during mannitol administration, recorded in drops per minute. Higher values indicate faster infusion delivery.

    Measured: During infusion, up to approximately 45 minutes

  3. Total infusion duration (minutes)

    Total duration of intravenous mannitol infusion, measured in minutes from the start to the completion of the full 250 mL infusion. Lower values indicate shorter infusion duration.

    Measured: From infusion start to completion of the full 250 mL infusion, up to approximately 45 minutes

  4. Intraocular pressure measured by iCare rebound tonometry at 30 minutes after infusion

    Intraocular pressure measured using an iCare rebound tonometer. Results are reported in mmHg. Lower values indicate lower intraocular pressure.

    Measured: 30 minutes after completion of the full 250 mL infusion

  5. Change in intraocular pressure measured by iCare rebound tonometry

    Change in intraocular pressure from pre-infusion measurement to the measurement obtained 30 minutes after completion of the full 250 mL infusion, assessed using an iCare rebound tonometer and reported in mmHg. Higher positive values indicate greater reduction in intraocular pressure.

    Measured: From pre-infusion baseline to 30 minutes after completion of the full 250 mL infusion

  6. Request for slowing or temporary interruption of infusion due to infusion-related discomfort/pain

    Whether the participant requested slowing or temporary interruption of the infusion because of infusion-related discomfort or pain. Reported as yes/no.

    Measured: During infusion, up to approximately 45 minutes

  7. Pain affecting mood or rest

    Whether infusion-related pain affected participant mood or rest during treatment. Reported as yes/no.

    Measured: During infusion, up to approximately 45 minutes

  8. Grade I phlebitis assessed by clinical observation

    Occurrence of infusion-related phlebitis assessed clinically by the nursing team according to local routine practice. Reported as yes/no.

    Measured: During infusion and immediately after completion of infusion, up to approximately 1 hour

  9. Local redness, swelling, or induration assessed by clinical observation

    Occurrence of local infusion-site redness, swelling, or induration assessed clinically by the nursing team. Reported as yes/no.

    Measured: During infusion and immediately after completion of infusion, up to approximately 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2026
  2. Study start9 Jan 2025
  3. Primary completion27 Jul 2025
  4. Study completion27 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants were randomly assigned in a parallel manner to receive intravenous mannitol infusion either with an infusion warming device or without warming. Each participant was assigned to one study arm only.
Masking
None (open label)
Enrolment
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07495449
Sponsor's protocol ID
EC 20240924(7)-P07
Status last verified
Mar 2026
First submitted
17 Mar 2026
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No individual participant data are planned to be shared. The study investigators do not plan to make de-identified individual-level data publicly available.

Publications

  • Lam DS, Chua JK, Tham CC, Lai JS. Efficacy and safety of immediate anterior chamber paracentesis in the treatment of acute primary angle-closure glaucoma: a pilot study. Ophthalmology. 2002 Jan;109(1):64-70. doi: 10.1016/s0161-6420(01)00857-0.

    PubMed 11772581
  • Lam DS, Lai JS, Tham CC, Chua JK, Poon AS. Argon laser peripheral iridoplasty versus conventional systemic medical therapy in treatment of acute primary angle-closure glaucoma : a prospective, randomized, controlled trial. Ophthalmology. 2002 Sep;109(9):1591-6. doi: 10.1016/s0161-6420(02)01158-2.

    PubMed 12208703
  • Marsh N, Larsen EN, Ullman AJ, Mihala G, Cooke M, Chopra V, Ray-Barruel G, Rickard CM. Peripheral intravenous catheter infection and failure: A systematic review and meta-analysis. Int J Nurs Stud. 2024 Mar;151:104673. doi: 10.1016/j.ijnurstu.2023.104673. Epub 2023 Dec 9.

    PubMed 38142634
  • Wang W. Tolerability of hypertonic injectables. Int J Pharm. 2015 Jul 25;490(1-2):308-15. doi: 10.1016/j.ijpharm.2015.05.069. Epub 2015 May 29.

    PubMed 26027488
  • Guanche-Sicilia A, Sanchez-Gomez MB, Castro-Peraza ME, Rodriguez-Gomez JA, Gomez-Salgado J, Duarte-Climents G. Prevention and Treatment of Phlebitis Secondary to the Insertion of a Peripheral Venous Catheter: A Scoping Review from a Nursing Perspective. Healthcare (Basel). 2021 May 19;9(5):611. doi: 10.3390/healthcare9050611.

    PubMed 34069674
  • Liang Z, Li H, Hou X, Yang K, Lv K, Ma Y, Lu Y, Wu K, Wu H. Prospective study on the role of preoperative mannitol in capsulorhexis and reducing intraoperative complications in primary angle-closure disease surgery. J Int Med Res. 2025 Jan;53(1):3000605241310106. doi: 10.1177/03000605241310106.

    PubMed 39817367

Questions about this trial

What is this clinical trial studying?

A study testing Infusion Warming Device and Routine Non-Warmed Mannitol Infusion in people with Acute Ocular Hypertension Glaucoma and Intraocular Hypertension, run by Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak pain score during infusion measured by the 11-point Numeric Rating Scale (NRS) (time frame: During infusion, up to approximately 45 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07495449, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

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