Health Condition 1: H53-H54- Visual disturbances and blindness
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients who meet the following criteria will be selected for the study: 1. Patients aged 10 to 45 years. 2. Patients diagnosed with myopia with spherical equivalent refractive error between minus 0.5 to minus 6.0 diopters. 3. Patients with stable refractive status for at least six months prior to enrollment. 4. Patients without any systemic disease that may affect ocular health, such as uncontrolled diabetes or autoimmune disorders. 5. Patients who are able and willing to provide written informed consent and are likely to complete the entire course of the study as per instructions.
Exclusion criteria
Exclusion criteria: Patients will be excluded from enrollment if they have: 1. High myopia with spherical equivalent refractive error greater than minus 6.0 diopters. 2. History of ocular surgery, such as refractive or cataract surgery, within the past one year. 3. Presence of ocular pathology other than myopia, such as glaucoma, retinal detachment, or macular degeneration. 4. Female patients who are pregnant, planning pregnancy during the study period, or lactating. 5. Current use or planned use of contact lenses during the study period. 6. Severe dry eye syndrome or any ocular surface disease that may affect study outcomes. 7. Use of ocular medications such as topical steroids or anti-glaucoma drugs that may interfere with the assessment of outcomes. 8. In cases of bilateral myopia, both eyes will be considered for inclusion in the study. 9. Inability to continue the proposed duration of treatment or attend follow-up visits. 10. Current participation in another clinical trial or participation in an ocular clinical trial within the past three months. 11. Development of any complications during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a. To determine the mean change in visual acuity at the end of treatment compared with baseline. b. To determine the mean change in the spherical equivalent of refraction at the end of treatment compared with baseline. Timepoint: day 0, day 7, day 23, day 29, day 45, and day 52. | — |
Secondary
| Measure | Time frame |
|---|---|
| a. To determine the mean change in keratometry readings at the end of treatment compared with baseline. b. To determine the mean change in axial length at the end of treatment compared with baseline. c. To determine the mean change in anterior chamber depth at the end of treatment compared with baseline. d. To determine the mean change in intraocular pressure at the end of treatment compared with baseline. Timepoint: day 0, day 7, day 23, day 29, day 45, and day 52 | — |
Countries
India
Contacts
Government Ayurvedic College and Hospital, Kadamkuan, Patna, Bihar, India.