Myopia, ModerateNCT06839898
A Prospective, Randomized Clinical Study of Two Phakic Toric Implantable Lenses
A study testing EYECRYLTM Phakic Toric Intraocular Lens Treatment Arm and Visian® Toric ICL Treatment Arm in people with Myopia, Moderate and Myopic Astigmatism, run by Biotech Healthcare Holding Gmbh at 4 sites in 2 countries.
Trial summary
Primary Objective: To compare the efficacy and the residual refractive error of EYECRYLTM Phakic toric versus Visian® Toric ICL in moderate to high myopic patient with co-existing astigmatism. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Myopia, Moderate, Myopic Astigmatism, Myopia, Degenerative
- What is being tested?
- EYECRYLTM Phakic Toric Intraocular Lens Treatment Arm and Visian® Toric ICL Treatment Arm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 10 Oct 2021to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 21 years old or older.
- Calculated IOL Power is within the range of the investigational IOLs
- Corneal Cylindrical error within the range defined in the clinical investigation plan
- Subject has monocular UCVA 0.5 LogMAR or worse
- Subject has had a stable refraction (±0.5D; ±1.0D for higher refractive errors), as expressed by manifest refraction spherical equivalent (MRSE) for a minimum 12 months prior to surgery, verified by consecutive refractions and/or medical records or prescription history.
- Subject, who is a current contact lens wearer, needs to demonstrate a stable refraction (±0.5D) expressed as MRSE, on two consecutive examination dates and stability of the refraction is determined by the following criteria:
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- Contact lenses were not worn for at least 2 weeks or 3 days prior to the first refraction.
- Two refractions were performed at least 7 days apart.
- Subject, who is expected to have residual postoperative cylindrical refractive error of ≥1D, has been given the opportunity to experience his/her best spectacle vision with the anticipated correction.
- Expected dilated pupil size at least large enough to visualize the axis marking.
- Patients willing to attend all follow-up appointments
- Patients must sign and be given a copy of the written Informed Consent form
Who cannot join
- Subject with acute and chronic disease or illness that would increase the operative risk or confound the outcomes of the evaluation.
- Subject taking systematic medication that can confound the outcome of the study or increase the risk to the subject
- Subject with ocular condition that may predispose the subject to future complications
- Subject with previous intraocular or corneal surgery
- Subject with less than the minimum endothelial cell density 2000 cells/mm² at the time of enrollment
- Pregnant or planning to become pregnant, or is lactating during the course of the evaluation
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- Other condition associated with fluctuation of hormones
- ACD measured from the endothelium lower than 2.8 mm
- Concurrent participation in another drug or device evaluation.
- Any cataract of any grade.
- Coefficient of variation of endothelial cell area >0.45
- Percent Hexagonality of endothelial cell shape ≤ 45%
- Monocular subject
- Vulnerable subjects as defined in section 12.3.10
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Germany3 sites, 3 recruiting
- Recruiting
Precise Vision Augentagesklinik Greven
Münster, North Rhine-Westphalia, 48268
Clinical Study Coordinator, Optometrist, 0049 0 800 3 100 900, e.diepenbrock@precisevision.de
- Recruiting
Precise Vision Augentagesklinik Rheine
Rheine, North Rhine-Westphalia, 48429
Clinical Study Coordinator, Optometrist, 0049 0 800 3 100 900, a.gerling@precise.vision
- Recruiting
Precise Vision Augentagesklinik Rheine
Steinfurt, North Rhine-Westphalia, 48429
Clinical Study Coordinator, Optometrist, 0049 0 800 3 100 900, a.gerling@precise.vision
India1 site, 1 recruiting
- Recruiting
Netradhama Superspeciality Eye Hospital
Bangalore, Karnataka, 560 082
Clinical Study Coordinator, MsC., 009196 935 01981, research@nethradhama.org
About this study
Official title: A Prospective, Randomized Clinical Study of Two Phakic Toric Implantable Lenses to Compare Outcomes in Patients With Moderate to High Myopia and Astigmatism
Primary Objective: To compare the efficacy and the residual refractive error of EYECRYLTM Phakic toric versus Visian® Toric ICL in moderate to high myopic patient with co-existing astigmatism. Secondary Objectives: To evaluate and compare the safety of EYECRYLTM Phakic toric versus Visian® Toric ICL in moderate to high myopic patients with co-existing astigmatism.
Read the detailed description
Phakic intraocular lenses are clear implantable lenses that are surgically placed either in anterior chamber (AC) or posterior chamber (PC) without removing the natural lens, enabling light to focus on the retina for improved uncorrected visual acuity. Phakic intraocular lenses demonstrate high optical quality and potential gain in visual acuity in myopic patients due to retinal magnification. Toric version of phakic intraocular lens is intended to correct both myopia and astigmatism.1
- Conditions
- Myopia, Moderate, Myopic Astigmatism, Myopia, Degenerative
- Being tested
- EYECRYLTM Phakic Toric Intraocular Lens Treatment Arm, Visian® Toric ICL Treatment Arm
- Medical subject headings
- Myopia, Lymphoma, Follicular, Astigmatism, Myopia, Degenerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EYECRYLTM Phakic Toric Intraocular Lens Treatment ArmDevice
The patients will be implanted with Eyecryl Phakic IOL at this arm based on randomization.Phakic intraocular lenses are clear implantable lenses that are surgically placed either in anterior chamber (AC) or posterior chamber (PC) without removing the natural lens, enabling light to focus on the retina for improved uncorrected visual acuity. Phakic intraocular lenses demonstrate high optical quality and potential gain in visual acuity in myopic patients due to retinal magnification. Toric version of phakic intraocular lens is intended to correct both myopia and astigmatism.
Visian® Toric ICL Treatment ArmDevice
The patients will be implanted with Visian® Toric Implantable Contact Lens at this arm based on randomization. Phakic intraocular lenses are clear implantable lenses that are surgically placed either in anterior chamber (AC) or posterior chamber (PC) without removing the natural lens, enabling light to focus on the retina for improved uncorrected visual acuity. Phakic intraocular lenses demonstrate high optical quality and potential gain in visual acuity in myopic patients due to retinal magnification. Toric version of phakic intraocular lens is intended to correct both myopia and astigmatism.
| Study group | Role | What they receive |
|---|---|---|
| EYECRYLTM Phakic Toric Intraocular Lens Treatment Arm | Experimental | Patients will be implanted with Eyecryl Phakic Toric IOL based on randomization. Receives: Device: EYECRYLTM Phakic Toric Intraocular Lens Treatment Arm |
| Visian® Toric ICL Treatment Arm | Active comparator | Patients will be implanted with Visian® Toric ICL based on randomization. Receives: Device: Visian® Toric ICL Treatment Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean residual refractive error
The mean residual refractive error in the study lens population that is equivalent to the mean residual refractive error of the control lens within +/- 0.50 Diopters at the 6-months post-op visit.
Measured: 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start10 Oct 2021
- Primary completionAug 2025 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia, ModerateStudies of the same condition, open and under way.
- 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
- Model description
- Phakic intraocular lenses are clear implantable lenses that are surgically placed either in anterior chamber (AC) or posterior chamber (PC) without removing the natural lens, enabling light to focus on the retina for improved uncorrected visual acuity. Phakic intraocular lenses demonstrate high optical quality and potential gain in visual acuity in myopic patients due to retinal magnification. Toric version of phakic intraocular lens is intended to correct both myopia and astigmatism
- Masking
- None (open label)
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotech Healthcare Holding Gmbh
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839898
- Sponsor's protocol ID
- BTVCPL-PHAKICTORIC-2019-13
- Other IDs
- CIV- 20-09-034764
- Status last verified
- Feb 2025
- First submitted
- 9 Jan 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Clinical Study of Two Phakic Toric Implantable Lenses to Compare Outcomes in Patients With Moderate to High Myopia and Astigmatism
- ClinicalTrials.gov ID
- NCT06839898
- Acronym / sponsor ID
- BTVCPL-PHAKICTORIC-2019-13
- Conditions
- Myopia, Moderate, Myopic Astigmatism, Myopia, Degenerative
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Biotech Healthcare Holding GmbhIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 21 Feb 2025 (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.
Primary Objective: To compare the efficacy and the residual refractive error of EYECRYLTM Phakic toric versus Visian® Toric ICL in moderate to high myopic patient with co-existing astigmatism. Secondary Objectives: To evaluate and compare the safety of EYECRYLTM Phakic toric versus Visian® Toric ICL in moderate to high myopic patients with co-existing astigmatism.
Detailed description
Phakic intraocular lenses are clear implantable lenses that are surgically placed either in anterior chamber (AC) or posterior chamber (PC) without removing the natural lens, enabling light to focus on the retina for improved uncorrected visual acuity. Phakic intraocular lenses demonstrate high optical quality and potential gain in visual acuity in myopic patients due to retinal magnification. Toric version of phakic intraocular lens is intended to correct both myopia and astigmatism.1
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phakic intraocular lenses are clear implantable lenses that are surgically placed either in anterior chamber (AC) or posterior chamber (PC) without removing the natural lens, enabling light to focus on the retina for improved uncorrected visual acuity. Phakic intraocular lenses demonstrate high optical quality and potential gain in visual acuity in myopic patients due to retinal magnification. Toric version of phakic intraocular lens is intended to correct both myopia and astigmatism
| Arm | Type | Receives |
|---|---|---|
| EYECRYLTM Phakic Toric Intraocular Lens Treatment Arm | Experimental | Device: EYECRYLTM Phakic Toric Intraocular Lens Treatment ArmPatients will be implanted with Eyecryl Phakic Toric IOL based on randomization. |
| Visian® Toric ICL Treatment Arm | Active comparator | Device: Visian® Toric ICL Treatment ArmPatients will be implanted with Visian® Toric ICL based on randomization. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients 21 years old or older.
- Calculated IOL Power is within the range of the investigational IOLs
- Corneal Cylindrical error within the range defined in the clinical investigation plan
- Subject has monocular UCVA 0.5 LogMAR or worse
- Subject has had a stable refraction (±0.5D; ±1.0D for higher refractive errors), as expressed by manifest refraction spherical equivalent (MRSE) for a minimum 12 months prior to surgery, verified by consecutive refractions and/or medical records or prescription history.
Key exclusion criteria (14 listed)
- Subject with acute and chronic disease or illness that would increase the operative risk or confound the outcomes of the evaluation.
- Subject taking systematic medication that can confound the outcome of the study or increase the risk to the subject
- Subject with ocular condition that may predispose the subject to future complications
- Subject with previous intraocular or corneal surgery
- Subject with less than the minimum endothelial cell density 2000 cells/mm² at the time of enrollment
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 |
|---|---|---|
| EYECRYLTM Phakic Toric Intraocular Lens Treatment ArmThe patients will be implanted with Eyecryl Phakic IOL at this arm based on randomization.Phakic intraocular lenses are clear implantable lenses that are surgically placed either in anterior chamber (AC) or posterior chamber (PC) without removing the natural lens, enabling light to focus on the retina for improved uncorrected visual acuity. Phakic intraocular lenses demonstrate high optical quality and potential gain in visual acuity in myopic patients due to retinal magnification. Toric version of phakic intraocular lens is intended to correct both myopia and astigmatism. | Device | EYECRYLTM Phakic Toric Intraocular Lens Treatment Arm |
| Visian® Toric ICL Treatment ArmThe patients will be implanted with Visian® Toric Implantable Contact Lens at this arm based on randomization. Phakic intraocular lenses are clear implantable lenses that are surgically placed either in anterior chamber (AC) or posterior chamber (PC) without removing the natural lens, enabling light to focus on the retina for improved uncorrected visual acuity. Phakic intraocular lenses demonstrate high optical quality and potential gain in visual acuity in myopic patients due to retinal magnification. Toric version of phakic intraocular lens is intended to correct both myopia and astigmatism. | Device | Visian® Toric ICL Treatment Arm |
Primary outcome
The mean residual refractive error
Time frame: 6 Month
The mean residual refractive error in the study lens population that is equivalent to the mean residual refractive error of the control lens within +/- 0.50 Diopters at the 6-months post-op visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: No
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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.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EYECRYLTM Phakic Toric Intraocular Lens Treatment Arm and Visian® Toric ICL Treatment Arm in people with Myopia, Moderate and Myopic Astigmatism, run by Biotech Healthcare Holding Gmbh at 4 sites in 2 countries.
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 12 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, India. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BHARGAV D JOSHI, M.Sc. (917966823000 ext. 203, bhargav.joshi@biotechhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean residual refractive error (time frame: 6 Month). 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 21 Feb 2025.