Myopia, Myopic Astigmatism, Refractive Errors
Conditions
Keywords
Refractive surgery, Phakic intraocular lens, ICL vault
Brief summary
This prospective non-comparative interventional study aims to analyse the pre-operative factors affecting the range of optimal ICL vaulting. the main question is what is the correlation between age, gender, spherical equivalent, white to white, anterior chamber volume and depth and postoperative vault? participants will do preoperative investigations ( specular microscopy, pentacam and biometry ) then refractive surgery (ICL implantation) followed by follow-up visits to assess the post-operative ICL vault and visual outcome.
Detailed description
Procedure: Refractive error correction by implantable contact lens ( ICL) will be preceded by a Preoperative assessment of the patient's anterior segment using specular Microscopy, pentacam and biometry and full ophthalmic examination. Post-operatively, visual acuity evaluation, intraocular pressure, and anterior and posterior segments examination using a slit lamp will be done on days 1 and 3 and then repeated after 1 month and 6 months Assessment of ICL vault measurement using pentacam scheimpflug imaging after 1 and 6 months will be done then a correlation between the ICL vault and the patient's refractive error and preoperative anterior segments parameters will be evaluated
Interventions
PROCEDURERefractive Surgery
Phakic implantable contact lens ( ICL)
Sponsors
Kasr El Aini Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Age:21 - 45 years old. * High Myopia or Myopic astigmatism. * Patients with stable preoperative refraction for the previous 12 months. * Aqueous depth (ACD internal) = 2.8 mm or greater from the endothelial side using pentacam. * Patients who are not fit for LASIK. * No previous intraocular surgeries.
Exclusion criteria
* Patients with endothelial cell count \< 2800 cells /mm2 * Patients with corneal opacities * Patients with preoperative glaucoma, cataract, and retinal disease. * Patients with any systemic diseases especially collagen diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ICL vault size | 1 month | assessment of ICL vault by scheimpflug image |
| ICL Vault size | 6 months | assessment of ICL vault by scheimpflug image |
| Post Operative UCVA and BCVA | 1-3 days | assessment of Post Operative visual acuity |
| Post Operative IOP | 1 - 3 days | assessment of post operative intraocular pressure |
Countries
Egypt
Outcome results
None listed