PresbyopiaNCT03836898
Presbyopic Phakic Intraocular Lens for Myopia Correction
A study testing Presbyopic posterior chamber phakic intraocular lens IPCL in people with Presbyopia and Myopia, run by Gemini Eye Clinic at 1 site in Czechia.
Trial summary
This is a prospective single-center study of implantations of the presbyopic version of phakic intraocular lens IPCL (EyeolUK, United Kingdom). Read more about this study
- Who is it for?
- Ages 38 to 50 years
- Conditions the study is for
- Presbyopia, Myopia
- What is being tested?
- Presbyopic posterior chamber phakic intraocular lens IPCL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2016to 31 Dec 2018
- 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 38 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- CDVA < 0.3 LogMAR
- Presbyopia with moderate to high myopia
- Phakic
Who cannot join
- Corneal endotehleial cell density below 2000 cells/mm2
- Corneal dystrophies
- ACD less than 2.8 mm
- history or current uveitis
- acute ocular inflammation
- glaucoma
Show all 9Show fewer
- chronic uveitis
- previous intraocular or refractive surgery
- preexisting ocular pathologic which may affect postoperative results
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective single-center study of implantations of the presbyopic version of phakic intraocular lens IPCL (EyeolUK, United Kingdom).
Read the detailed description
Participants are impanted with the phakic intraocular lens IPCL (EyeolUK, United Kingdom) and monitored during 2 years period. Visual acuity for near and distance is evaluated, along with refraction and endothelium cell density.
- Conditions
- Presbyopia, Myopia
- Being tested
- Presbyopic posterior chamber phakic intraocular lens IPCL
- Medical subject headings
- Presbyopia, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Presbyopic posterior chamber phakic intraocular lens IPCLDevice
Presbyopic posterior chamber phakic intraocular lens IPCL (EyeolUK, United Kingdom) has a refractive optic and diffractive trifocal pattern on its anterior optical surface to correct both distance and near refractive errors. Presbyopic addition is manufactured in a range of +1.0 to + 4.0 diopters (D) in 0.5 D steps.
| Study group | Role | What they receive |
|---|---|---|
| Implantation phakic intraocular lens | Experimental | Presbyopic posterior chamber phakic intraocular lens IPCL implanted to the participants eye Receives: Device: Presbyopic posterior chamber phakic intraocular lens IPCL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Uncorrected Distance Visual Acuity (UDVA)
Distance visual acuity tested without any correction
Measured: 2 years
Change in Uncorrected Near Visual Acuity (UNVA)
Near visual acuity tested without any correction
Measured: 2 years
Secondary outcomes (4)
Change in Corrected Distance Visual Acuity (CDVA)
Distance visual acuity tested with correction
Measured: 2 years
Change in Corrected Near Visual Acuity (CNVA)
Near visual acuity tested with correction
Measured: 2 years
Change in distance refraction
Expressed as spherical equivalent sp.Eq (D)
Measured: 2 years
Change in near refraction
Expressed as spherical equivalent sp.Eq (D)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start1 Jan 2016
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PresbyopiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gemini Eye Clinic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836898
- Sponsor's protocol ID
- PhakicIOL Presbyopia
- Status last verified
- Feb 2019
- First submitted
- 6 Feb 2019
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Stodulka P, Slovak M, Sramka M, Polisensky J, Liska K. Posterior chamber phakic intraocular lens for the correction of presbyopia in highly myopic patients. J Cataract Refract Surg. 2020 Jan;46(1):40-44. doi: 10.1097/j.jcrs.0000000000000033.
PubMed 32050231
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presbyopic Phakic Intraocular Lens for Myopia Correction
- ClinicalTrials.gov ID
- NCT03836898
- Acronym / sponsor ID
- PhakicIOL Presbyopia
- Conditions
- Presbyopia, Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Gemini Eye ClinicIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 11 Feb 2019 (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.
This is a prospective single-center study of implantations of the presbyopic version of phakic intraocular lens IPCL (EyeolUK, United Kingdom).
Detailed description
Participants are impanted with the phakic intraocular lens IPCL (EyeolUK, United Kingdom) and monitored during 2 years period. Visual acuity for near and distance is evaluated, along with refraction and endothelium cell density.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantation phakic intraocular lens | Experimental | Device: Presbyopic posterior chamber phakic intraocular lens IPCLPresbyopic posterior chamber phakic intraocular lens IPCL implanted to the participants eye |
Who may qualify
- Ages
- 38 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- CDVA < 0.3 LogMAR
- Presbyopia with moderate to high myopia
- Phakic
Key exclusion criteria (9 listed)
- Corneal endotehleial cell density below 2000 cells/mm2
- Corneal dystrophies
- ACD less than 2.8 mm
- history or current uveitis
- acute ocular inflammation
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 |
|---|---|---|
| Presbyopic posterior chamber phakic intraocular lens IPCLPresbyopic posterior chamber phakic intraocular lens IPCL (EyeolUK, United Kingdom) has a refractive optic and diffractive trifocal pattern on its anterior optical surface to correct both distance and near refractive errors. Presbyopic addition is manufactured in a range of +1.0 to + 4.0 diopters (D) in 0.5 D steps. | Device | Implantation phakic intraocular lens |
Primary outcome
Change in Uncorrected Distance Visual Acuity (UDVA)
Time frame: 2 years
Distance visual acuity tested without any correction
Change in Uncorrected Near Visual Acuity (UNVA)
Time frame: 2 years
Near visual acuity tested without any correction
4 secondary outcomes
Change in Corrected Distance Visual Acuity (CDVA)
Time frame: 2 years
Change in Corrected Near Visual Acuity (CNVA)
Time frame: 2 years
Change in distance refraction
Time frame: 2 years
Change in near refraction
Time frame: 2 years
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 10 May 2019.
- Derived from this study: PubMed 32050231Stodulka P, Slovak M, Sramka M, Polisensky J, Liska K. Posterior chamber phakic intraocular lens for the correction of presbyopia in highly myopic patients. J Cataract Refract Surg. 2020 Jan;46(1):40-44. doi: 10.1097/j.jcrs.0000000000000033.
- Individual participant dataSharing planned: Undecided
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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. 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 Presbyopic posterior chamber phakic intraocular lens IPCL in people with Presbyopia and Myopia, run by Gemini Eye Clinic at 1 site in Czechia.
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 3 inclusion and 9 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 10 May 2019. 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 Czechia. 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?
Change in Uncorrected Distance Visual Acuity (UDVA) (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03836898, which also lists 1 linked publication.
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 10 May 2019; AzTrials last refreshed its copy on 1 Nov 2026.