EASE OF MAKING ARTIFICIAL EYE WITH AND WITHOUT CONSCIOUS SEDATION USING MIDAZOLAM : A PILOT STUDY
Not Applicable
- Conditions
- Health Condition 1: C692- Malignant neoplasm of retina
- Registration Number
- CTRI/2023/04/051465
- Lead Sponsor
- ANSHU BAID
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Subjects aged 1-14 years of age
Subjects with unilateral enucleation, evisceration or exenteration.
Exclusion Criteria
Subjects under the age of 1 year or body weight <10 kg
Subjects with any form of acute disease
Subjects with respiratory or cardiac disease that affects daily life
Subjects with neuromuscular diseases as myasthenia gravis
Subjects with allergy to benzodiazepine
Subjects with sleep apnoea.
Subjects with liver dysfunction (dose adjustment may be necessary)
Subjects with hepatic dysfunction (dose adjustment may be necessary)
Subjects with porphyria
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate prosthetic outcome & ease of fabrication of ocular prosthesis in pediatric subjects with and without conscious sedation.Timepoint: At each appointment when step of ocular prosthesis fabrication is done.
- Secondary Outcome Measures
Name Time Method The primary outcome is ease of fabrication of prosthesis whereas secondary outcome is time taken during ocular prosthesis fabrication, use of physical restraints during prosthesis fabrication and comparison of above parameters based on age and gender. <br/ ><br>Timepoint: To fill the pre-validated questionnaire at each appointment of ocular prosthesis fabrication