NCT05670626

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

December 14, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 4, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

2.8 years

First QC Date

December 11, 2022

Last Update Submit

March 10, 2025

Conditions

Refractive ErrorsMyopiaMyopic Astigmatism

Keywords

Refractive surgeryPhakic intraocular lensICL vault

Outcome Measures

Primary Outcomes (8)

  • ICL vault size

    assessment of ICL vault by scheimpflug image

    1 month

  • ICL Vault size

    assessment of ICL vault by scheimpflug image

    6 months

  • Post Operative UCVA and BCVA

    assessment of Post Operative visual acuity

    1-3 days

  • Post Operative UCVA and BCVA

    assessment of Post Operative visual acuity

    1 month

  • Post Operative UCVA and BCVA

    assessment of Post Operative visual acuity

    6 months

  • Post Operative IOP

    assessment of post operative intraocular pressure

    1 - 3 days

  • Post Operative IOP

    assessment of post operative intraocular pressure

    1 month

  • Post Operative IOP

    assessment of post operative intraocular pressure

    6 month

Study Arms (1)

non comparative interventional study

OTHER

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

Interventions

Refractive SurgeryPROCEDURE

Phakic implantable contact lens ( ICL)

non comparative interventional study

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alwatany Eye Hospital

Cairo, Cairo Governorate, 00000, Egypt

Location

MeSH Terms

Conditions

Refractive ErrorsMyopiaAstigmatism

Interventions

Refractive Surgical Procedures

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • 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 DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ophthalmology consultant

Study Record Dates

First Submitted

December 11, 2022

First Posted

January 4, 2023

Study Start

December 14, 2022

Primary Completion

October 1, 2025

Study Completion

December 1, 2025

Last Updated

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)