clinical trial to ensure the safety and efficacy of Phakic intraocular lenses in high myopic patients
- Conditions
- Health Condition 1: H55-H57- Other disorders of eye and adnexa
- Registration Number
- CTRI/2023/04/051897
- Lead Sponsor
- Aurolab
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 <20mmHg
f) Anterior chamber depth of atleast 2.8 mm and angle <33 degree (from pentacam)
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
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 <2.8 mm and angle <33 degree
h) Pregnancy and lactation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method a) Uncorrected visual acuity <br/ ><br>b) Best corrected visual acuity <br/ ><br>c) Intraocular Pressure <br/ ><br>d) Endothelial cell count <br/ ><br>e) Post operative inflammationTimepoint: day 1 one month <br/ ><br>three months <br/ ><br>six months <br/ ><br>12 months <br/ ><br>18 months <br/ ><br>24 months
- Secondary Outcome Measures
Name Time Method visual acuity <br/ ><br>Post operative complications <br/ ><br>Contrast sensitivityTimepoint: 24 months