An interventional study of Infusion Warming Device and Routine Non-Warmed Mannitol Infusion in Acute Ocular Hypertension Glaucoma, Intraocular Hypertension and Primary Angle-Closure Glaucoma, sponsored by Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
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.
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.
91 studies on the registry are indexed under Glaucoma, Angle-Closure; 17 are open to participants now.
This study's enrollment of 142 is above the median of 57 across 58 interventional studies indexed under Glaucoma, Angle-Closure.
Browse Glaucoma, Angle-Closure studies →Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Participants received intravenous mannitol infusion using an infusion warming device during treatment for acute ocular hypertension.
Device: Infusion Warming Device
Participants received routine intravenous mannitol infusion without use of an infusion warming device during treatment for acute ocular hypertension.
Other: Routine Non-Warmed Mannitol Infusion
An infusion warming device was used during intravenous mannitol administration to warm the infused fluid according to the study protocol.
Intravenous mannitol was administered according to routine clinical practice without infusion warming.
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.
Time frame: During infusion, up to approximately 45 minutes
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.
Time frame: During infusion, up to approximately 45 minutes
Maximum infusion rate (drops/minute)
Maximum achievable intravenous infusion rate during mannitol administration, recorded in drops per minute. Higher values indicate faster infusion delivery.
Time frame: During infusion, up to approximately 45 minutes
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.
Time frame: From infusion start to completion of the full 250 mL infusion, up to approximately 45 minutes
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.
Time frame: 30 minutes after completion of the full 250 mL infusion
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.
Time frame: From pre-infusion baseline to 30 minutes after completion of the full 250 mL infusion
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.
Time frame: During infusion, up to approximately 45 minutes
Pain affecting mood or rest
Whether infusion-related pain affected participant mood or rest during treatment. Reported as yes/no.
Time frame: During infusion, up to approximately 45 minutes
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.
Time frame: During infusion and immediately after completion of infusion, up to approximately 1 hour
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.
Time frame: During infusion and immediately after completion of infusion, up to approximately 1 hour
Plan to share: 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.
Ran from Jan 2025 to primary completion in Jul 2025, 6 months.
Of 28 interventional studies with no phase under Glaucoma, Angle-Closure, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 43. This study's 6 months is below that.
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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong