NCT06058780

Brief Summary

Phakic intraocular lenses (pIOL) have proven to be a great alternative to corneal refractive surgery in certain situations. They offer several advantages over corneal techniques, such as being suitable for high myopes and causing relatively fewer higher-order aberrations. In addition, pIOLs have been shown to provide better retinal image magnification and higher contrast sensitivity compared to laser in situ keratomileusis, regardless of whether the myopia is low or high.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

September 22, 2023

Last Update Submit

September 22, 2023

Conditions

Myopia

Outcome Measures

Primary Outcomes (12)

  • UCVA

    Uncorrected Visual Acuity measured in decimal

    Baseline

  • UCVA

    Uncorrected Visual Acuity measured in decimal

    3 months postoperative

  • UCVA

    Uncorrected Visual Acuity measured in decimal

    6 months postoperative

  • UCVA

    Uncorrected Visual Acuity measured in decimal

    12 months postoperative

  • BCVA

    Best corrected Visual Acuity measured in decimal

    Baseline

  • BCVA

    Best corrected Visual Acuity measured in decimal

    3 months postoperative

  • BCVA

    Best corrected Visual Acuity measured in decimal

    6 months postoperative

  • BCVA

    Best corrected Visual Acuity measured in decimal

    12 months postoperative

  • Refraction

    Preoperative refractive error measured in spherical equivalent

    Baseline

  • Refraction

    postoperative refractive error measured in spherical equivalent

    3 months postoperative

  • Refraction

    postoperative refractive error measured in spherical equivalent

    6 months postoperative

  • Refraction

    postoperative refractive error measured in spherical equivalent

    12 months postoperative

Study Arms (2)

Implantable Collamer Lens (ICL)

ACTIVE COMPARATOR
Procedure: Implantable Collamer Lens (ICL)

Implantable Intraocular Lens (IPCL)

ACTIVE COMPARATOR
Procedure: Implantable Intraocular Lens (IPCL)

Interventions

Implantable Collamer Lens (ICL)PROCEDURE

Phakic intraocular lenses (pIOL) have proven to be a great alternative to corneal refractive surgery in certain situations. They offer several advantages over corneal techniques, such as being suitable for high myopes and causing relatively fewer higher-order aberrations

Implantable Collamer Lens (ICL)
Implantable Intraocular Lens (IPCL)PROCEDURE

The IPCL offers a distinct economic advantage as the cost of the IPCL implant is only 2. times that of the ICL implant. Moreover, the IPCL can correct higher degrees of myopia, up to -30. D, compared to the maximum correction of -18. D provided by the ICL.

Implantable Intraocular Lens (IPCL)

Eligibility Criteria

Age20 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • myopia of more than 6 diopter

You may not qualify if:

  • unstable refraction
  • unstable refraction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akram Fekry Elgazzar

Damietta, 34517, Egypt

Location

MeSH Terms

Conditions

Myopia

Interventions

Lenses, Intraocular

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

LensesOptical DevicesEquipment and SuppliesProstheses and Implants

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 22, 2023

First Posted

September 28, 2023

Study Start

August 1, 2021

Primary Completion

August 1, 2023

Study Completion

September 1, 2023

Last Updated

September 28, 2023

Record last verified: 2023-09

Locations

EG(1)