Phase 4
Completed N=124
Cool vs Room-temperature Artificial Tears
Diabetic Retinopathy With Macular Edema of Both Eyes (Diagnosis) · Central Retinal Vein Occlusion With Macular Edema · Exudative Age-Related Macular Degeneration, Unspecified Eye · Cystoid Macular Edema
Source: ClinicalTrials.gov NCT05832996 ↗
Enrolled (actual)
124
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: The Efficacy of Cooled Versus Room Temperature Artificial Tears in Reducing Post Intravitreal Injection Ocular Discomfort as Measured by Pain Scale Survey. — 2.21; 1.95 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Background and Objective: To evaluate the efficacy of cooled versus room temperature artificial tears in reducing post intravitreal injection (IVI) ocular discomfort.
Patients and Methods: Patients receiving IVI were randomized to either cooled or room temperature tears intervention groups. Both groups rated their ocular discomfort following IVI before intervention and again after administration of cooled or room temperature tears.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Efficacy of Cooled Versus Room Temperature Artificial Tears in Reducing Post Intravitreal Injection Ocular Discomfort as Measured by Pain Scale Survey. |
2.21; 1.95 | — |
Eligibility Criteria
Inclusion Criteria
- Patients were eligible if they were receiving standard intravitreal injections for their exudative age-related macular degeneration, cystoid macular edema, diabetic macular edema, proliferative diabetic retinopathy, retinal vein occlusion with macular edema, or retinal neovascularization.
Exclusion Criteria
- Inability or lack of willingness to participate in the study
- Active ocular infection including infectious uveitis
- First time receiving intravitreal injection
- Those who reported never having ocular discomfort following intravitreal injections on the pre-injection questionnaire
- Less than 18 years of age
Data sourced from ClinicalTrials.gov (NCT05832996). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.