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Correlation Between Preoperative Refraction and Anterior Segment Parameters With ICL Vault

Primary Purpose

Refractive Errors, Myopia, Myopic Astigmatism

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Refractive Surgery
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Refractive Errors focused on measuring Refractive surgery, Phakic intraocular lens, ICL vault

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • Alwatany Eye HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

non comparative interventional study

Arm 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

Outcomes

Primary Outcome Measures

ICL vault size
assessment of ICL vault by scheimpflug image
ICL Vault size
assessment of ICL vault by scheimpflug image
Post Operative UCVA and BCVA
assessment of Post Operative visual acuity
Post Operative UCVA and BCVA
assessment of Post Operative visual acuity
Post Operative UCVA and BCVA
assessment of Post Operative visual acuity
Post Operative IOP
assessment of post operative intraocular pressure
Post Operative IOP
assessment of post operative intraocular pressure
Post Operative IOP
assessment of post operative intraocular pressure

Secondary Outcome Measures

Full Information

First Posted
December 11, 2022
Last Updated
January 1, 2023
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05670626
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors, Myopia, Myopic Astigmatism
Keywords
Refractive surgery, Phakic intraocular lens, ICL vault

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
non comparative interventional study
Arm Type
Other
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Refractive Surgery
Intervention Description
Phakic implantable contact lens ( ICL)
Primary Outcome Measure Information:
Title
ICL vault size
Description
assessment of ICL vault by scheimpflug image
Time Frame
1 month
Title
ICL Vault size
Description
assessment of ICL vault by scheimpflug image
Time Frame
6 months
Title
Post Operative UCVA and BCVA
Description
assessment of Post Operative visual acuity
Time Frame
1-3 days
Title
Post Operative UCVA and BCVA
Description
assessment of Post Operative visual acuity
Time Frame
1 month
Title
Post Operative UCVA and BCVA
Description
assessment of Post Operative visual acuity
Time Frame
6 months
Title
Post Operative IOP
Description
assessment of post operative intraocular pressure
Time Frame
1 - 3 days
Title
Post Operative IOP
Description
assessment of post operative intraocular pressure
Time Frame
1 month
Title
Post Operative IOP
Description
assessment of post operative intraocular pressure
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nermine S. Madkour, DR
Phone
01002822290
Ext
01007912799
Email
nerminesaid81@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ramy R Fikry, Ass Prof
Phone
01223141345
Email
riaddoss@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adel M Fathy, Prof. DR
Organizational Affiliation
Faculty of medicine Kasr El Aini
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ramy R Fikry, Ass prof
Organizational Affiliation
Faculty of medicine Kasr El Aini
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed A Anis, Ass Prof
Organizational Affiliation
Faculty of medicine Kasr El Aini
Official's Role
Study Director
Facility Information:
Facility Name
Alwatany Eye Hospital
City
Cairo
ZIP/Postal Code
00000
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nermine s Madkour, DR
Phone
01002822290
Ext
01007912799
Email
nerminesaid81@yahoo.com
First Name & Middle Initial & Last Name & Degree
Ramy R Fikry, Ass. Prof
Phone
01223141345
Ext
Madkour
Email
nerminesaid81@yahoo.com
First Name & Middle Initial & Last Name & Degree
Nermine s Madkour, DR
First Name & Middle Initial & Last Name & Degree
Adel F Fathy, Prof. DR
First Name & Middle Initial & Last Name & Degree
Ramy R Fikry, Ass. Prof
First Name & Middle Initial & Last Name & Degree
Mohamed A Anis, Ass. prof

12. IPD Sharing Statement

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Correlation Between Preoperative Refraction and Anterior Segment Parameters With ICL Vault

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