Correlation Between Preoperative Refraction and Anterior Segment Parameters with ICL Vault

Not Applicable

• Conditions: Refractive Errors; Myopia; Myopic Astigmatism
• Interventions: Procedure: Refractive Surgery

• Registration Number: NCT05670626
• Lead Sponsor: Kasr El Aini Hospital

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

Study Timeline

• Study First Submitted: 2022-12-11
• Study Start: 2022-12-14
• Study First Submitted QC: 2023-01-01
• Study First Posted: 2023-01-04
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-13
• Primary Completion: 2025-10
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
non comparative interventional study	Refractive Surgery	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

Primary Outcome Measures

Name	Time	Method
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	6 months	assessment of Post Operative visual acuity
Post Operative IOP	6 month	assessment of post operative intraocular pressure

Trial Locations

Locations (1)

Alwatany Eye Hospital; 🇪🇬 Cairo, Egypt