Myopia control efficacy of Spectacle lenses with Highly aspherical lenslets (HAL) in high myopia.
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in axial length
Study Overview
Brief Summary
This prospective controlled clinical trial will be conducted in Myopia Research Lab, L V Prasad Eye Institute, Hyderabad, and the study protocol will adhere to the tenets of Declaration of Helsinki. Participants will be recruited based on the inclusion and exclusion criteria either from The Infor Myopic Clinic, L V Prasad Eye Institute, Hyderabad or by advertisement in local media (newspaper), or approaching schools for referrals. An informed consent will be obtained from each participant (parent/guardian of participating child) after explaining the nature of the study. Assent will be obtained from the participating children. Detailed ocular and medical history will be elicited followed by comprehensive examination (visual acuity, slit lamp examination, open-field autorefraction, subjective refraction), pupillometry, specialty tests such as binocular vision assessments, axial length measurement, peripheral refraction, optical coherence tomography, corneal topography. All participants will undergo cycloplegic refraction after instillation of Tropicamide 1% eye drops. Measurements will be obtained thirty minutes after instillation of eye drops. Eligible participants will be called for the dispensing visit and then following study visits at 3 month, 6 months and 12 months. In each follow-up visits, the required ocular parameters such as visual acuity, slit lamp examination, axial length, peripheral refraction, open field autorefraction, subjective refraction, pupillometry, optical coherence tomography, corneal topography along with participant’s compliance to the spectacles provided will be assessed to analyze the efficacy of these spectacles in controlling myopia progression.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 6.00 Year(s) to 14.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Age between 6 to 14 years inclusive at time of enrolment 2.Interested in wearing spectacles for 5 days per week and 6 hours in a day 3.Best-corrected high contrast visual acuity based on manifest refraction of 0.18 logMAR 4.spherical equivalent-6.00 D to -11
- •astigmatic component 0 DC to -3.0DC 6.Spherical equivalent anisometropia less than or equal to 2.50 D.
Exclusion Criteria
- •1.Current or prior use of ANY form of myopia control strategy 2.Participant born earlier than 30 weeks or weighed less than 1500 gm at birth 3.Any ocular, systemic, or neuro-developmental conditions that may influence refractive error 4.Manifest strabismus (tropia) 5.Any known ocular inflammation or infection.
Outcomes
Primary Outcomes
Change in axial length
Time Frame: 3 Months, 6 months and 12 months
Secondary Outcomes
- change in spherical equivalent refractive error(Base line, 3,6, 12 months)
Investigators
DrPavan Verkicharla
L V Prasad Eye Institute