| CTRI Number |
CTRI/2019/05/018970 [Registered on: 07/05/2019] Trial Registered Prospectively |
| Last Modified On: |
04/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Atropine eyedrops for preventing increase in refractive error (shortsight and astigmatism) |
|
Scientific Title of Study
|
Low strength atropine (0.01%) eyedrops for preventing progression of Compound Myopic Astigmatism in children and young adults-
A Randomised Controlled Trial
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| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1218-2668 |
UTN |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abraham Kurian |
| Designation |
Medical Superintendent and Senior Consultant |
| Affiliation |
Chaithanya Eye Hospital and Research Institute |
| Address |
Level 2,
Room No: 2002,
Chaithanya Eye Hospital and Research Institute, Kesavadasapuram, Trivandrum
Kesavadasapuram
Thiruvananthapuram
KERALA
695004
India |
| Phone |
|
| Fax |
|
| Email |
abrahamkurian55@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Iodine Reghunadhan |
| Designation |
Consultant |
| Affiliation |
Chaithanya Eye Hospital and Research Institute |
| Address |
Comprehensive Ophthalmology,
Level 2,
Room No: 2001,
Chaithanya Eye Hospital and Research Institute, Kesavadasapuram, Trivandrum
Kesavadasapuram
Thiruvananthapuram
KERALA
695004
India |
| Phone |
|
| Fax |
|
| Email |
iodine_b@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Iodine Reghunadhan |
| Designation |
Consultant |
| Affiliation |
Chaithanya Eye Hospital and Research Institute |
| Address |
Comprehensive ophthalmology,
Level 2,
Room No: 2001,
Chaithanya Eye Hospital and Research Institute, Kesavadasapuram, Trivandrum
Kesavadasapuram
Thiruvananthapuram
KERALA
695004
India |
| Phone |
|
| Fax |
|
| Email |
iodine_b@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Chaithanya Eye Hospital and Research Institute, Trivandrum |
|
|
Primary Sponsor
|
| Name |
DrAbraham Kurian |
| Address |
Chaithanya Eye Hospital and Research Institute, Trivandrum |
| Type of Sponsor |
Other [Principal Investigator] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Iodine Reghunadhan |
Chaithanya Eye Hospital and Research Institute |
Comprehensive Ophthalmology,
Level 2
Room No:2001
Thiruvananthapuram
KERALA |
9847104830
iodine_b@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chaithanya Eye Hospital and Research Institute-Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H522||Astigmatism, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Atropine |
Atropine 0.01% eyedrops 1 drop HS in the randomised eye for 1 year |
| Comparator Agent |
NIL |
Atropine eyedrops will be used only in one eye of each patient.Te other eye will receive no treatment.The eye to be treated will be assigned by randomisation |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Children or Young adults in the age group 5-15 years.
2. Myopic refractive error of spherical equivalent > 1.00D as measured by cycloplegic refraction
3. Astigmatism of > 1.50D as measured by cycloplegic refraction
4. Documented progression of myopic component of Compound Myopic astigmatism
5. Ability to understand and follow the study instructions you receive and likely to be amenable for 1 year followup.
6. Normal ocular health other than refractive error
7. Normal Intraocular pressure (<21 mm Hg)
|
|
| ExclusionCriteria |
| Details |
1. Known Allergy or hypersensitivity to Atropine, Cyclopentolate, Phenyl ephrine or Proparacaine
2. Amblyopia in atleast one eye
3. History of significant cardiac or respiratory illness
4. Current enrolment in another investigational study or participation in such a study within 30 days of entry into this study
5. No previous or current use of contact lenses or bifocals or progressive lenses or other forms of treatment (including Atropine in any strength) for myopia
6. Patient has a condition or situation which in the investigators opinion, may put the patient at a significant risk, may confound the study results, or interfere with the participation in the study.
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome will be progression of the myopic component of Compound Myopic astigmatism estimated as the change in spherical equivalent refractive error relative to the baseline |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome will be the change in axial length with respect to the baseline measurement. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
08/05/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Chia A, Chua WH, Wen L, et al. Atropine for the treatment of childhood myopia: changes after stopping atropine 0.01%, 0.1% and 0.5%. Am J Ophthalmol. 2014;157:451–7 e1.
Chia A, Lu QS, Tan D. Five-year clinical trial on atropine for the treatment of myopia 2: myopia control with atropine 0.01% eyedrops. Ophthalmology. 2016;123:391–9.
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
STUDY OBJECTIVE : To evaluate the efficacy and safety of low strength atropine eyedrops 0.01% in preventing progression of compound myopic astigmatism in children and young adults CLINICAL HYPOTHESIS : Low dose atropine (0.01%) eyedrops is effective in preventing or slowing down the progression of myopic component of Compound myopic astigmatism in children as well as young adults, with minimal or insignificant side effects.
Single centre, Randomised Controlled Trial; Parallel group, Intervetional study design
The primary outcome will be progression of the myopic component of Compound Myopic astigmatism estimated as the change in spherical equivalent refractive error relative to the baseline. The secondary outcome will be the change in axial length with respect to the baseline measurement. The ATOM studies established the effect of Atropine in preventing the progression of low to moderate myopia and it was concluded that at low strength of 0.01% the drug showed optimum efficacy with minimal side effects and minimal rebound. However the study failed to study high myopes (>6 D) and children above 12 years while myopic progression can continue in young adults. Also the study duration was limited which fails to bring out the persistence of the long term results. The study also excluded eyes with coexisting astigmatism > 1.5D In our experience it is seen that Compound Myopic astigmatism is the most common refractive error in children in our population, rather than Simple Myopia and the myopic component of Compound Myopic astigmatism has been shown to progress as in simple myopia. So we designed this study to study the efficacy of low strength Atropine (0.01%) in the Indian population, to assess its efficacy in Compound myopic astigmatism and to assess the persistence of the efficacy as well as the safety profile for a longer period. Also we intended to include a higher age group ie upto 15 years (Inclusion age: 5-15 years) which was not included in the ATOM studies.
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