Pain during pan-retinal photocoagulation for diabetic retinopathy Diabetic retinopathy
Conditions
Interventions
Ketamine hydrochloride eye drops were prepared by a pharmacist at a final concentration of 0.5 percent in sterile normal saline with physiological pH of 6.5 to 7.0. The solution was colorless, stored
Experimental Drug,Placebo Comparator Drug
Topical ketamine 0.5% eye drops plus routine topical tetracaine,Placebo eye drops plus routine topical tetracaine
Sponsors
Tehran University of MedicalSciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1- Adult diabetic patients older than 18 years. 2- Bilateral diabetic retinopathy requiring pan-retinal photocoagulation. 3- Severe non-proliferative diabetic retinopathy or early proliferative diabetic retinopathy. 4- No previous retinal laser treatment. 5- Ability and willingness to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1- Vitreous hemorrhage. 2- Advanced proliferative diabetic retinopathy. 3- Significant cataract interfering with adequate pan-retinal photocoagulation. 4- Inability to tolerate pan-retinal photocoagulation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective ocular pain intensity immediately after pan-retinal photocoagulation Immediately after each pan-retinal photocoagulation procedure. 11-point Numeric Rating Scale for pain, ranging from 0 to 10. | — |
Secondary
| Measure | Time frame |
|---|---|
| Ocular and systemic adverse events During and after each treatment session throughout study participation. Clinical monitoring and participant reporting of adverse events throughout the study, including ocular irritation, ocular complications, dizziness, dissociative symptoms, cardiovascular symptoms | — |
Countries
Iran
Contacts
Public ContactNader Mohammadi
Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran
Outcome results
None listed