Correlation Between Preoperative Refraction and Anterior Segment Parameters with ICL Vault

Kasr El Aini Hospital

Status: Invitation-only

Conditions: Myopia; Refractive Errors; Myopic Astigmatism

Treatments: Procedure: Refractive Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05670626

MD-360-2021

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

non comparative interventional study

Other group

Description:

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

Treatment:

Procedure: Refractive Surgery