To study the use of atropine(0.01%)eye drops in halting progression of myopia

Recruiting

Brief Summary: The prevalence of myopia has increased worldwide in recent decades. Atropine eye drops can slow myopia progression by an average of -â€‰0.54 dioptres (D)/year in Asian children and -â€‰0.35â€‰D/year in Caucasian children. It is an Open label case control prospective study which will be conducted at AIIMS ,JODHPUR ,RAJASTHAN with sample size of 125 eligible patients in each group to compare the efficacy and safety of atropine 0.01% eye drops in controlling myopic progression in children. Group A: receiving atropine eye drops 0.01% OD along with subjective correction of refraction with spectacles or contact lenses in both eyes. Group B: receiving only subjective correction of refraction. All patients will undergo complete ophthalmic and systemic evaluation. A follow-up visit will be done after 3 months (+/-7 days), 6 months (+/-7 days), 1 year (+/-7 days), 18 months (+/-7 days) and 24 months (+/-7 days) of first visit. Primary Endpoints will be Change in spherical equivalent at the end of 2 years. Data pertaining to demographic details, clinical investigations, will be recorded in predesigned format and data will be transferred to an Excel spreadsheet. In case of side effects , the same drug will be discontinued and treated with an alternative standard drug.

Recruitment & Eligibility

Inclusion Criteria

1.All patients with age group 05 to 23 years.
2.Gender male and female 3.Best corrected visual acuity should be 6/6 (20/20; LogMAR 0.0) or better in both eyes 4.Spherical equivalent should be equal to or more than -0.25Diopter 5.Both spherical and or cylindrical refraction would be included.
Refraction would be based on cycloplegic refraction and subjective acceptance 6.Patients/legal guardian should be willing to use the eye drops on regular compliant basis.
7.Patients/legal guardian should be able to understand and sign an informed consent.

Exclusion Criteria

1.History of ocular inflammation or trauma or treatment of refractive error (medical or surgical) 2.Any ocular comorbidity limiting visual assessment, visual improvement.
3.Any type of amblyopia in one or both eyes.
4.Patient lost to follow up within 1 year of the study or not compliant with the treatment advised.

Primary Outcome Measures

Name	Time	Method
Primary:	Change in spherical equivalent at the end of 2 years.
To compare the the efficacy and safety of atropine 0.01% eye drops in controlling progression of myopia.	Change in spherical equivalent at the end of 2 years.
To evaluate the systemic and ocular side effects of atropine eye drops 0.01% in myopic patients.	Change in spherical equivalent at the end of 2 years.
Secondary :	Change in spherical equivalent at the end of 2 years.

Secondary Outcome Measures

Name	Time	Method
To evaluate the efficacy of atropine 0.01% eye drops in arresting the progression of myopia	To evaluate the efficacy of atropine 0.01% eye drops in arresting the progression of myopia at 2 year of therapy

Locations (1): AIIMS Jodhpur
🇮🇳
Jodhpur, RAJASTHAN, India
AIIMS Jodhpur
🇮🇳Jodhpur, RAJASTHAN, India
Dr Arvind Kumar Morya
Principal investigator
9812403786
moryaak@aiimsjodhpur.edu.in