Correlation Between Preoperative Refraction and Anterior Segment Parameters With ICL Vault

Sponsor

Kasr El Aini Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05670626

Collaborator

(none)

Enrollment

Location

Arm

9.6

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Refractive Errors Myopia Myopic Astigmatism	Procedure: Refractive Surgery	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Dec 14, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

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 [1-3 days]
assessment of Post Operative visual acuity
Post Operative UCVA and BCVA [1 month]
assessment of Post Operative visual acuity
Post Operative UCVA and BCVA [6 months]
assessment of Post Operative visual acuity
Post Operative IOP [1 - 3 days]
assessment of post operative intraocular pressure
Post Operative IOP [1 month]
assessment of post operative intraocular pressure
Post Operative IOP [6 month]
assessment of post operative intraocular pressure

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alwatany Eye Hospital	Cairo		Egypt	00000

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nermine Said Aly Madkour, ophthalmology consultant, Kasr El Aini Hospital

ClinicalTrials.gov Identifier:

NCT05670626

Other Study ID Numbers:

MD-360-2021

First Posted:

Jan 4, 2023

Last Update Posted:

Jan 4, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nermine Said Aly Madkour, ophthalmology consultant, Kasr El Aini Hospital

Refractive surgery

Phakic intraocular lens

ICL vault

Additional relevant MeSH terms:

Astigmatism

Refractive Errors

Study Results

No Results Posted as of Jan 4, 2023