Correlation Between Preoperative Refraction and Anterior Segment Parameters With ICL Vault

January 1, 2023 updated by: Nermine Said Aly Madkour, Kasr El Aini Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 00000
        • Recruiting
        • Alwatany Eye Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nermine s Madkour, DR
        • Sub-Investigator:
          • Adel F Fathy, Prof. DR
        • Sub-Investigator:
          • Ramy R Fikry, Ass. Prof
        • Sub-Investigator:
          • Mohamed A Anis, Ass. prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICL vault size
Time Frame: 1 month
assessment of ICL vault by scheimpflug image
1 month
ICL Vault size
Time Frame: 6 months
assessment of ICL vault by scheimpflug image
6 months
Post Operative UCVA and BCVA
Time Frame: 1-3 days
assessment of Post Operative visual acuity
1-3 days
Post Operative UCVA and BCVA
Time Frame: 1 month
assessment of Post Operative visual acuity
1 month
Post Operative UCVA and BCVA
Time Frame: 6 months
assessment of Post Operative visual acuity
6 months
Post Operative IOP
Time Frame: 1 - 3 days
assessment of post operative intraocular pressure
1 - 3 days
Post Operative IOP
Time Frame: 1 month
assessment of post operative intraocular pressure
1 month
Post Operative IOP
Time Frame: 6 month
assessment of post operative intraocular pressure
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2022

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

December 11, 2022

First Submitted That Met QC Criteria

January 1, 2023

First Posted (Estimate)

January 4, 2023

Study Record Updates

Last Update Posted (Estimate)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 1, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD-360-2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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