Health Condition 1: H55-H57- Other disorders of eye and adnexa
Conditions
Interventions
Intervention1: Phakic intraocular lens: Phakic intraocular lens is an innovative emerging technology with an optical design intended to correct widest range of myopia (nearsightedness) hyperopia (fars
Sponsors
Aurolab
Eligibility
Inclusion criteria
Inclusion criteria: a) Adults of > 21 years b) Stable refraction atleast for 1 year c) Myopia and Myopic astigmatism less than 1 D of corneal astigmatism d) Clear intraocular media e) Intraocular pressure of f) Anterior chamber depth of atleast 2.8 mm and angle g) Endothelial cell count >2500 cells/mm2 h) Normal posterior segment i) AS OCT (Open angles) j) Abnormal elevation and curvature maps not fit for corneal refractive surgery. k) understand and willing to participate in the study for 2 years of follow up period l) No systemic illness
Exclusion criteria
Exclusion criteria: a) Participation in any other drug or device clinical trial within 90 days prior to enrolling in this study and/or during study participation b) corneal pathologic conditions like degenerations and dystrophies and keratoconus c) Evidence of any lens opacity or developing cataract, pseudoexfoliation or pigmentory dispersion d) History of glaucoma and uveitis e) Previous history of ocular diseases f) History of any intraocular or corneal surgery in either eye (including LASIK PRK LRI etc) g) Anterior chamber depth h) Pregnancy and lactation
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| visual acuity Post operative complications Contrast sensitivityTimepoint: 24 months | — |
Primary
| Measure | Time frame |
|---|---|
| a) Uncorrected visual acuity b) Best corrected visual acuity c) Intraocular Pressure d) Endothelial cell count e) Post operative inflammationTimepoint: day 1 one month three months six months 12 months 18 months 24 months | — |
Countries
India
Contacts
Public ContactDr Meenakshi Ravindran
Aravind Eye Hospital
Outcome results
None listed