MyopiaNCT06058780
Safety and Efficacy of Implantable Collamer Lens Versus Implantable Phakic Lens IPCL in Myopic Patients; A Comparative Study
A study testing Implantable Collamer Lens (ICL) and Implantable Intraocular Lens (IPCL) in people with Myopia, run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 25 years
- Conditions the study is for
- Myopia
- What is being tested?
- Implantable Collamer Lens (ICL) and Implantable Intraocular Lens (IPCL)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2021to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- myopia of more than 6 diopter
Who cannot join
- unstable refraction
- unstable refraction
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Myopia
- Being tested
- Implantable Collamer Lens (ICL), Implantable Intraocular Lens (IPCL)
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Collamer Lens (ICL)Procedure or surgery
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 Intraocular Lens (IPCL)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Implantable Collamer Lens (ICL) | Active comparator | Not described Receives: Procedure: Implantable Collamer Lens (ICL) |
| Implantable Intraocular Lens (IPCL) | Active comparator | Not described Receives: Procedure: Implantable Intraocular Lens (IPCL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
UCVA
Uncorrected Visual Acuity measured in decimal
Measured: Baseline
UCVA
Uncorrected Visual Acuity measured in decimal
Measured: 3 months postoperative
UCVA
Uncorrected Visual Acuity measured in decimal
Measured: 6 months postoperative
UCVA
Uncorrected Visual Acuity measured in decimal
Measured: 12 months postoperative
BCVA
Best corrected Visual Acuity measured in decimal
Measured: Baseline
BCVA
Best corrected Visual Acuity measured in decimal
Measured: 3 months postoperative
BCVA
Best corrected Visual Acuity measured in decimal
Measured: 6 months postoperative
BCVA
Best corrected Visual Acuity measured in decimal
Measured: 12 months postoperative
Refraction
Preoperative refractive error measured in spherical equivalent
Measured: Baseline
Refraction
postoperative refractive error measured in spherical equivalent
Measured: 3 months postoperative
Refraction
postoperative refractive error measured in spherical equivalent
Measured: 6 months postoperative
Refraction
postoperative refractive error measured in spherical equivalent
Measured: 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 Aug 2021
- Primary completion1 Aug 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akram Fekry Elgazzar, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058780
- Sponsor's protocol ID
- ICL vs IPCL
- Status last verified
- Sep 2023
- First submitted
- 22 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Implantable Collamer Lens Versus Implantable Phakic Lens IPCL in Myopic Patients; A Comparative Study
- ClinicalTrials.gov ID
- NCT06058780
- Acronym / sponsor ID
- ICL vs IPCL
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implantable Collamer Lens (ICL) | Active comparator | Procedure: Implantable Collamer Lens (ICL) |
| Implantable Intraocular Lens (IPCL) | Active comparator | Procedure: Implantable Intraocular Lens (IPCL) |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- myopia of more than 6 diopter
Key exclusion criteria (2 listed)
- unstable refraction
- unstable refraction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantable Collamer Lens (ICL)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 | Procedure or surgery | Implantable Collamer Lens (ICL) |
| Implantable Intraocular Lens (IPCL)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. | Procedure or surgery | Implantable Intraocular Lens (IPCL) |
Primary outcome
UCVA
Time frame: Baseline
Uncorrected Visual Acuity measured in decimal
UCVA
Time frame: 3 months postoperative
Uncorrected Visual Acuity measured in decimal
UCVA
Time frame: 6 months postoperative
Uncorrected Visual Acuity measured in decimal
UCVA
Time frame: 12 months postoperative
Uncorrected Visual Acuity measured in decimal
BCVA
Time frame: Baseline
Best corrected Visual Acuity measured in decimal
BCVA
Time frame: 3 months postoperative
Best corrected Visual Acuity measured in decimal
BCVA
Time frame: 6 months postoperative
Best corrected Visual Acuity measured in decimal
BCVA
Time frame: 12 months postoperative
Best corrected Visual Acuity measured in decimal
Refraction
Time frame: Baseline
Preoperative refractive error measured in spherical equivalent
Refraction
Time frame: 3 months postoperative
postoperative refractive error measured in spherical equivalent
Refraction
Time frame: 6 months postoperative
postoperative refractive error measured in spherical equivalent
Refraction
Time frame: 12 months postoperative
postoperative refractive error measured in spherical equivalent
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
Related trials for Myopia
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantable Collamer Lens (ICL) and Implantable Intraocular Lens (IPCL) in people with Myopia, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UCVA (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.