Clinical trial NCT05670626: Correlation Between Preoperative Refraction and Anterior Segment Parameters With ICL Vault
Official title: Correlation Between ICL Vault and Preoperative Refraction ( Spherical Equivalent) and Anterior Segment Parameters Measured by Optical Biometry and Scheimpflug Imaging
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Refractive Errors
Myopia
Myopic Astigmatism
Keywords: Refractive surgery
Phakic intraocular lens
ICL vault
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

Eligibility criteria: 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.

Primary outcomes:
measure: ICL vault size
timeFrame: 1 month
measure: ICL Vault size
timeFrame: 6 months
measure: Post Operative UCVA and BCVA
timeFrame: 1-3 days
measure: Post Operative UCVA and BCVA
timeFrame: 1 month
measure: Post Operative UCVA and BCVA
timeFrame: 6 months
measure: Post Operative IOP
timeFrame: 1 - 3 days
measure: Post Operative IOP
timeFrame: 1 month
measure: Post Operative IOP
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Alwatany Eye Hospital
Study officials:
affiliation: Faculty of medicine Kasr El Aini
name: Adel M Fathy, Prof. DR
role: STUDY_DIRECTOR
affiliation: Faculty of medicine Kasr El Aini
name: Ramy R Fikry, Ass prof
role: STUDY_DIRECTOR
affiliation: Faculty of medicine Kasr El Aini
name: Mohamed A Anis, Ass Prof
role: STUDY_DIRECTOR
References: