Correlation Between Preoperative Refraction and Anterior Segment Parameters with ICL Vault

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Refractive Errors; Myopia; Myopic Astigmatism
• Intervention / Treatment: Procedure: Refractive Surgery

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 00000
    • Alwatany Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Procedure: Refractive Surgery; Phakic implantable contact lens ( ICL)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital
• Investigators: Study Director: Adel M Fathy, Prof. DR, Faculty of medicine Kasr El Aini; Study Director: Ramy R Fikry, Ass prof, Faculty of medicine Kasr El Aini; Study Director: Mohamed A Anis, Ass Prof, Faculty of medicine Kasr El Aini

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2022
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 11, 2022
• First Submitted That Met QC Criteria: January 1, 2023
• First Posted (Actual): January 4, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Refractive surgery; Phakic intraocular lens; ICL vault
• Additional Relevant MeSH Terms: Eye Diseases; Astigmatism; Refractive Errors
• Other Study ID Numbers: MD-360-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No