CataractNCT03320473
IOL Implantation After KAMRA Inlay Removal
A study testing IC-8 IOL in people with Cataract and Presbyopia, run by AcuFocus, Inc. at 1 site in Philippines.
Trial summary
A. The primary purpose of the study is to evaluate outcomes of aphakic eyes implanted with the IC-8 IOL following cataract removal in prior inlay patients after KAMRA inlay removal. B. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract, Presbyopia
- What is being tested?
- IC-8 IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 sitePhilippines
- Study dates
- 5 Dec 2017to 20 Jun 2022
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must sign and be given a copy of the informed consent form. ii. Subjects with BCDVA of 20/40 or worse, or significant visual symptoms/complaints as a result of cataract in the study eye.
- Subjects must be > 45 years of age at the time of screening. iv. Subjects must be willing and able to return for scheduled follow up examinations for 12 months after surgery.
- Subjects who underwent uneventful KAMRA inlay implantation and who currently still have the inlay in the eye.
- Potential visual acuity following cataract removal and IOL implantation projected to be 0.8 or better (Snellen 20/25) as determined by diagnostic testing or investigator's medical judgment.
Who cannot join
- Patients who had any type of intraocular surgery or refractive surgery (with the exception of KAMRA inlay implantation).
- Requiring an intraocular lens outside the available power range of +15.5 to +27.5 diopters.
- Pharmacologically dilated pupil size less than 6 mm or the presence of any pupil abnormalities (aniridia, non-reactive, fixed, or abnormally shaped pupils) or marked microphthalmos.
- Preoperative corneal astigmatism > 1.5 diopters (as determined by corneal topography or keratometry in either eye) or irregular corneal astigmatism.
- Corneal abnormalities such as stromal, epithelial or endothelial dystrophies, or diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level of 0.8 or worse during the study.
- Active or recurrent anterior segment pathology (chronic uveitis, iritis, iridocyclitis, rubeosis iridis, etc.).
- Glaucoma suspect, uncontrolled ocular hypertension, or history of glaucomatous changes in the retina or visual field.
- Subjects with uncontrolled systemic disease. ix. Subjects with previous retinal pathology in either eye.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study of Small Aperture Intraocular Lens (IOL) Implantation in KAMRA Inlay Patients After Inlay Removal
- The primary purpose of the study is to evaluate outcomes of aphakic eyes implanted with the IC-8 IOL following cataract removal in prior inlay patients after KAMRA inlay removal.
- The secondary purpose of the study is to determine whether there are any changes in biometry measurements before and after the inlay removal and how the changes affect the calculated IOL power.
Read the detailed description
This will be a prospective study in which no more than 20 subjects will be implanted with IC-8 IOL following the removal of the KAMRA inlay. The refractive target of the IC-8 eye will be -0.75 D MRSE.
Subjects will be screened for eligibility and consented before enrolled. Following enrollment, the inlay will be removed, and the eye will be monitored for corneal and refractive stability before the implantation of the IC-8 IOL. Corneal stability is defined as keratometry readings in each meridian within ± 0.50 D, and/or the stability of the corneal topography as determined by the principal investigator, over two consecutive visits at least two weeks apart. Refractive stability is defined as manifest refractive sphere and cylinder measurements that are each within ± 0.50 D over two consecutive visits at least two weeks apart, or based on investigator judgment. When corneal and refractive stability are achieved, the IC-8 IOL will be implanted following cataract extraction by phacoemulsification.
- Conditions
- Cataract, Presbyopia
- Being tested
- IC-8 IOL
- Medical subject headings
- Cataract, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IC-8 IOLDevice
The AcuFocus IC-8 intraocular lens (IC-8 IOL) is a one-piece hydrophobic acrylic posterior chamber IOL into which a circular mask with a small 1.36 mm central aperture has been embedded. The IOL mask works by extending the depth of focus and its design is based on the KAMRA corneal inlay, which operates under the principle of small aperture optics.
| Study group | Role | What they receive |
|---|---|---|
| IC-8 IOL | Experimental | IC-8 IOL implantation after removal of KAMRA ACI 7000 PDT inlay Receives: Device: IC-8 IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCDVA
Mean monocular best-corrected distance visual acuity at three months is at least 0.3 logMAR
Measured: 3 months
Secondary outcomes (1)
UCNVA
b.1. Mean monocular uncorrected near visual acuity (UCNVA) at 40 cm at 3 months is at least 0.3 logMAR.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start5 Dec 2017
- Primary completion20 Jun 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- AcuFocus, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicholas Tarantino, OD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320473
- Sponsor's protocol ID
- IC-8 302 KAMR
- Status last verified
- May 2023
- First submitted
- 22 Oct 2017
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Small Aperture Intraocular Lens (IOL) Implantation in KAMRA Inlay Patients After Inlay Removal
- ClinicalTrials.gov ID
- NCT03320473
- Acronym / sponsor ID
- IC-8 302 KAMR
- Conditions
- Cataract, Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- AcuFocus, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Dec 2017 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 25 Oct 2017 (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.
- The primary purpose of the study is to evaluate outcomes of aphakic eyes implanted with the IC-8 IOL following cataract removal in prior inlay patients after KAMRA inlay removal.
- The secondary purpose of the study is to determine whether there are any changes in biometry measurements before and after the inlay removal and how the changes affect the calculated IOL power.
Detailed description
This will be a prospective study in which no more than 20 subjects will be implanted with IC-8 IOL following the removal of the KAMRA inlay. The refractive target of the IC-8 eye will be -0.75 D MRSE.
Subjects will be screened for eligibility and consented before enrolled. Following enrollment, the inlay will be removed, and the eye will be monitored for corneal and refractive stability before the implantation of the IC-8 IOL. Corneal stability is defined as keratometry readings in each meridian within ± 0.50 D, and/or the stability of the corneal topography as determined by the principal investigator, over two consecutive visits at least two weeks apart. Refractive stability is defined as manifest refractive sphere and cylinder measurements that are each within ± 0.50 D over two consecutive visits at least two weeks apart, or based on investigator judgment. When corneal and refractive stability are achieved, the IC-8 IOL will be implanted following cataract extraction by phacoemulsification.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IC-8 IOL | Experimental | Device: IC-8 IOLIC-8 IOL implantation after removal of KAMRA ACI 7000 PDT inlay |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must sign and be given a copy of the informed consent form. ii. Subjects with BCDVA of 20/40 or worse, or significant visual symptoms/complaints as a result of cataract in the study eye.
- Subjects must be > 45 years of age at the time of screening. iv. Subjects must be willing and able to return for scheduled follow up examinations for 12 months after surgery.
- Subjects who underwent uneventful KAMRA inlay implantation and who currently still have the inlay in the eye.
- Potential visual acuity following cataract removal and IOL implantation projected to be 0.8 or better (Snellen 20/25) as determined by diagnostic testing or investigator's medical judgment.
Key exclusion criteria (8 listed)
- Patients who had any type of intraocular surgery or refractive surgery (with the exception of KAMRA inlay implantation).
- Requiring an intraocular lens outside the available power range of +15.5 to +27.5 diopters.
- Pharmacologically dilated pupil size less than 6 mm or the presence of any pupil abnormalities (aniridia, non-reactive, fixed, or abnormally shaped pupils) or marked microphthalmos.
- Preoperative corneal astigmatism > 1.5 diopters (as determined by corneal topography or keratometry in either eye) or irregular corneal astigmatism.
- Corneal abnormalities such as stromal, epithelial or endothelial dystrophies, or diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level of 0.8 or worse during the study.
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 |
|---|---|---|
| IC-8 IOLThe AcuFocus IC-8 intraocular lens (IC-8 IOL) is a one-piece hydrophobic acrylic posterior chamber IOL into which a circular mask with a small 1.36 mm central aperture has been embedded. The IOL mask works by extending the depth of focus and its design is based on the KAMRA corneal inlay, which operates under the principle of small aperture optics. | Device | IC-8 IOL |
Primary outcome
BCDVA
Time frame: 3 months
Mean monocular best-corrected distance visual acuity at three months is at least 0.3 logMAR
1 secondary outcome
UCNVA
Time frame: 3 months
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 2023.
- 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.
Nicholas Tarantino, OD study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IC-8 IOL in people with Cataract and Presbyopia, run by AcuFocus, Inc. at 1 site in Philippines.
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 4 inclusion and 8 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 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 Philippines. 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?
BCDVA (time frame: 3 months). 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 10 May 2023.