Correlation Between Preoperative Refraction and Anterior Segment Parameters With ICL Vault

Study Overview
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Brief Summary
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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
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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

Official Title
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Correlation Between ICL Vault and Preoperative Refraction ( Spherical Equivalent) and Anterior Segment Parameters Measured by Optical Biometry and Scheimpflug Imaging

Conditions
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Refractive Errors, Myopia, Myopic Astigmatism

Intervention / Treatment
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* Procedure: Refractive Surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: non comparative interventional study<br>patients with high refractive error will do phakic ICL after preoperative assessment of anterior segments parameters and post-operative ICL vault will be measured using pentacam | Procedure: Refractive Surgery<br>* Phakic implantable contact lens ( ICL)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICL vault size | assessment of ICL vault by scheimpflug image | 1 month | 
| ICL Vault size | assessment of ICL vault by scheimpflug image | 6 months | 
| Post Operative UCVA and BCVA | assessment of Post Operative visual acuity | 1-3 days | 
| Post Operative UCVA and BCVA | assessment of Post Operative visual acuity | 1 month | 
| Post Operative UCVA and BCVA | assessment of Post Operative visual acuity | 6 months | 
| Post Operative IOP | assessment of post operative intraocular pressure | 1 - 3 days | 
| Post Operative IOP | assessment of post operative intraocular pressure | 1 month | 
| Post Operative IOP | assessment of post operative intraocular pressure | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Refractive surgery, Phakic intraocular lens, ICL vault