EVALUATION OF EFFICACY AND SAFETY OF TOPICAL OXYMETAZOLINE 0.1% OPHTHALMIC SOLUTION IN TREATMENT OF ACQUIRED PTOSIS
Phase 2
Completed
- Conditions
- Health Condition 1: H024- Ptosis of eyelid
- Registration Number
- CTRI/2022/08/044783
- Lead Sponsor
- DR RPCENTRE FOR OPHTHALMIC SCIENCES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
1.PATIENT WITH ACQUIRED PTOSIS
2.PATIENT WITHOUT HISTORY OF PTOSIS CORRECTION
3.PATIENT OR PARENTS WILLING TO GIVE CONSENT
Exclusion Criteria
1.PATIENTS DIAGNOSED AS CONGENITAL PTOSIS
2.PATIENTS WITH HORNER SYNDROME
3.PATIENTS WITH MYASTHENIA GRAVIS
4.PATIENTS HAVING MECHANICAL PTOSIS
5.PATIENTS WITH PSEUDOPTOSIS
6.PATIENTS WITH CEREBRAL OR CORONARY INSUFFICIENCY
7.SJOGREN SYNDROME PATIENTS
8.HYPERTENSIVE PATIENTS
9.GLAUCOMA PATIENTS
10.PATIENTS ON BETA BLOCKERS
11.PATIENTS ON ALPHA ADRENERGIC AGONISTS
12.PATIENTS ON CARDIAC GLYCOSIDES
13.PATIENTS ON MONOAMINE OXIDASE INHIBITORS
14.PATIENTS NOT WILLING TO FOLLOW UP
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.CHANGE FROM BASELINE IN MARGIN TO REFLEX DISTANCE(MRD 1) <br/ ><br>2.IMPROVEMENT IN VISUAL FIELDS ON HVF ANALYSIS <br/ ><br>Timepoint: BASELINE(DAY1), AT 1 WEEK, <br/ ><br>6 WEEKS, 7 WEEKS, 8 WEEKS, <br/ ><br>3 MONTHS
- Secondary Outcome Measures
Name Time Method 1.VISION ON SNELLEN VISUAL ACUITY CHART <br/ ><br>2.PUPILLARY DIAMETER TO BE MEASURED ON SLIT LAMP <br/ ><br>3.CORNEAL FLUORESCEIN STAINING ON SLIT LAMP <br/ ><br>4.TEAR FILM STABILITY BY DOING IMPRESSION CYTOLOGYTimepoint: DAY 1 DAY 14 AND DAY 42