Correlation Between Preoperative Refraction and Anterior Segment Parameters With ICL Vault

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-14

Study Completion Date

2025-12-31

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.

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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

Conditions

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Refractive Errors Myopia Myopic Astigmatism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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non comparative interventional study

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

Group Type OTHER

Refractive Surgery

Intervention Type PROCEDURE

Phakic implantable contact lens ( ICL)

Interventions

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Refractive Surgery

Phakic implantable contact lens ( ICL)

Intervention Type PROCEDURE

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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes