Correlation Between Preoperative Refraction and Anterior Segment Parameters With ICL Vault

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05670626
• Other study ID #: MD-360-2021
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2022
• Est. completion date: October 2023

Study information

• Verified date: January 2023
• Source: Kasr El Aini Hospital
• Contact: Nermine S. Madkour, DR
• Phone: 01002822290
• Email: nerminesaid81[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism
• Myopia
• Myopic Astigmatism
• Refractive Errors

Intervention

Procedure:
• Refractive Surgery
Phakic implantable contact lens ( ICL)

Locations

Country	Name	City	State
Egypt	Alwatany Eye Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICL vault size	assessment of ICL vault by scheimpflug image	1 month
Primary	ICL Vault size	assessment of ICL vault by scheimpflug image	6 months
Primary	Post Operative UCVA and BCVA	assessment of Post Operative visual acuity	1-3 days
Primary	Post Operative UCVA and BCVA	assessment of Post Operative visual acuity	1 month
Primary	Post Operative UCVA and BCVA	assessment of Post Operative visual acuity	6 months
Primary	Post Operative IOP	assessment of post operative intraocular pressure	1 - 3 days
Primary	Post Operative IOP	assessment of post operative intraocular pressure	1 month
Primary	Post Operative IOP	assessment of post operative intraocular pressure	6 month