New Drug trial in prevention of the progression of myopia in Indian children
- Conditions
- Myopia,
- Registration Number
- CTRI/2021/11/038177
- Lead Sponsor
- Dr Siddharam S Janti
- Brief Summary
Title of the project: **Safety and efficacy of Atropine 0.01% and 0.05% in prevention of the progression of Myopia in Indian children**
Objective of the study:
1) Quantitative assessment of change in refractive error before and after treatment of different concentrations of atropine
2) Measurement of axial length before and after treatment of different concentrations of atropine
3 ) Side effects of low concentration of atropine
Justification for conducting the study
The comparative studies of the use of Atropine 0.01% and 0.05% has its own merits , however the progression of myopia is shown to be less with the use of 0.05% Atropine. There is not sufficient data in the Indian scenario to conclusively state this.
**Detailed methodology including study design and outcome measures** :
This is an interventional case study will be conducted between 2021 and 2022 on children with confirmed myopia greater than �’ 1.0 D and less than -6.00D.
The study would take place at All India Institute of Medical Sciences , Bibinagar , Telangana over a period of 1year.
**Sample size** - 270 of age group 5-16 years. Both males and females will be included in the study .
Considering the pre and post mean (SD) of 0.05,0.01 and placebo groups RE and the between the groups differences, we require 68 study participants to observe statistical significant differences between 0.05 and placebo group and 103 participants for 0.05 and 0.01 atropine groups. However considering the feasibility of the study and the primary objective we will be recruiting 68 study participants in each group. With 20%drop out rate we will enroll 90 study participants in each group
Inclusion criteria : Age of 5 to 16 years with myopia – 1D to -6 D & an annual myopic progression of greater than 0.5 D.
Exclusion criteria :Exclusion criteria :
â— Refractive Myopia
◠Astigmatism ≥ 1.5 D
â— Amblyopia
â— Prior intraocular surgery
â— Allergy to atropine eye drops
â— Systemic diseases associated with myopia such as Marfan syndrome, Stickler syndrome
â— History of cardiac or significant respiratory diseases
â— Lack of consent for participating in the study
The sample will be divided into three groups . Each group comprising of 90 members . The selection will be random as per randomisation protocol .
Group A : will be provided with Atropine 0.01% eyedrops.
Group B: will be provided with Atropine 0.05% eye drops.
Group c : will be the control group , provided with the placebo ( CMC 0.5%)
-The candidates for study will be chosen among the patients attending the Ophthalmology OPD at All India Institute of Medical Sciences , Bibinagar. Each candidate will analyzed by measuring the cycloplegic refraction, intraocular pressure measurement,fundus examination,anterior chamber depth,pupillary diameter measurement ,axial length and accommodation amplitude.Cycloplegic refraction will be done by using The autorefractor-keratometer and retinoscopy. Intraocular pressure will be measured using Non contact tonometry. Slit lamp will be used to measure the fundus , pupillary diameter and the anterior chamber depth. Axial length of the eyeball will be measured using A-scan.Accommodation amplitude will be measured using the RAF ruler.
The candidate would be examined on the first day , 12 weeks later , 24 weeks and after 1 year.
At the end the study period , the ,measurements of the cycloplegic refraction , intraocular measurement , fundus examination , pupillary diameter , anterior chamber depth,axial length and accommodation amplitude will be recorded and compared for Atropine 0.01% and 0.05% separately along with the pharmacological side effects and the compliance of the drugs.
A questionnaire will be given to the subject and the attendant which contains questions regarding “visual impairment†, “reading difficultyâ€, “diplopiaâ€, “light sensitivity†or “glareâ€. Answers will be categorised as “ yes†or “noâ€. Then a comparison will be drawn between the two doses of the drug and the results will be obtained .
Timelines:
| | |
| --- | --- |
|Activities
Duration
|4 months
Enrolment of children & Randomisation
|Every 3 months
Follow up of children with assessment of progression of refractive error , axial length measurement and reporting of complications of atropine
|16 months
Data acquisition and statical analysis
Data analysis Plan
Data will be entered in Microsoft Excel and will be analysed in SPSS software 21 . Per protocol will be done. The categorical variables will be summarised using frequency and proportions and quantitative variables will be summarised by mean , standard deviation. The significance between the 2 grope will be assessed by Annova test and Bonferroni test . the effect size for the primary outcome variable will be calculated by standardized mean difference. The level of statical significant will be consider as 5%.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 270
1 )Age of 5 to 16 years 2 ) Myopia – 1D to -6 D 3 )Annual myopic progression of greater than 0.5 D.
â—Refractive Myopia â—Astigmatism ≥ 1.5 D â—Amblyopia â—Prior intraocular surgery â—Allergy to atropine eye drops â—Systemic diseases associated with myopia such as Marfan syndrome, Stickler syndrome â—History of cardiac or significant respiratory diseases â—Lack of consent for participating in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quantitative assessment of change in refractive error before and after treatment of different concentrations of atropine 3 , 6 and 12 months
- Secondary Outcome Measures
Name Time Method 1)Measurement of axial length before and after treatment of different concentrations of atropine 2 ) Side effects of low concentration of atropine
Trial Locations
- Locations (1)
All India institute Medical Sciences Bibinagar Hyderabad
🇮🇳Hyderabad, TELANGANA, India
All India institute Medical Sciences Bibinagar Hyderabad🇮🇳Hyderabad, TELANGANA, IndiaDr Siddharam S JantiPrincipal investigator9962171725drsiddharam@gmail.com