Health Condition 1: H521- Myopia
Conditions
Interventions
Intervention1: Eyecryl Biotech Vision Care phakic lens
: Phakic intraocular lens implantation in sulcus
Control Intervention1: Phakic intraocular lens: EVO/EVO+ Visian Implantable Collamer Lenses
Con
Sponsors
Prof MVanathi
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients with myopic astigmatism within a spherical equivalent (SE) range of -3.00 to -20.00 D and a minimum astigmatism of -1.00 D, stable refraction (0.50 D or less change in the past 12 months), 2.Minimum anterior chamber depth (ACD) from corneal endothelium of 2.8 mm, 3.Endothelial cell count of 2,500 cells/mm2 4.Absence of corneal ectatic diseases, corneal scars, 5.Absence of retinal pathologies 6.Patients willing to give written informed consent and attend all follow-up appointments
Exclusion criteria
Exclusion criteria: 1.Subject with previous intraocular or corneal surgery 2.Subject with ocular condition like any cataract of any grade, glaucoma, severe dry eye, herpetic keratitis, uveitis 3.Subject with systemic conditions like diabetes, collagen vascular diseases, immunosuppression 4.Subject who is Pregnant or planning to start family, or lactating during the course of the evaluation 5.Other condition associated with fluctuation of hormones 6.Monocular subject 7.Patient not willing to give written informed consent and attend all follow-up appointments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.The aim of this study is to evaluate and compare the visual and refractive outcome after implantation of Eyecryl, a hydrophilic acrylic phakic intraocular lens implant from Biotech Vision Care (EP IOL) in moderate and high myopia and astigmatism with an established method using Visian Implantable Collamer Lenses (EVO/EVO+ latest model of ICL, STAAR Surgical Company). Timepoint: day 1, 1month, 3month and 6 month and 12 month | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To assess and compare rotational stability after toric phakic intraocular lens implantation 2.To assess and compare the changes in the ocular parameters of the Anterior chamber angle, crystalline lens and axial length. 3.To assess and compare the adverse events occurred during Eyecryl phakic intraocular lens implantation and during follow upTimepoint: day 1, 1month, 3month and 6 month and 12 month | — |
Countries
India
Contacts
Public ContactDr Kusumitha
Dr Rajendra Prasad Centre for Ophthalmic Sciences AIIMS New Delhi
Outcome results
None listed