CataractNCT05069415
Monofocal IOL Visual Outcomes When Targeting Mini Monovision
A study testing Eyhance IOL in people with Cataract and Presbyopia, run by Carolina Eyecare Physicians, LLC at 2 sites in United States.
Trial summary
This study is a 3-month, prospective, up to 2 center, bilateral, randomized subject masked clinical evaluation of a monofocal intraocular lens (IOL) when both eyes are targeted for emmetropia and when the non-dominant eye is targeted for mini monovision (-0.75 D) in patients with or without astigmatism undergoing… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cataract, Presbyopia
- What is being tested?
- Eyhance IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Oct 2021to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is undergoing bilateral cataract extraction with intraocular lens implantation.
- Willing and able to provide written informed consent for participation in the study
- Willing and able to comply with scheduled visits and other study procedures.
- Scheduled to undergo standard cataract surgery in both eyes within 6 - 30 days between surgeries.
- Subjects who require an IOL power in the range of +5.0 D to +34.0 D only.
- Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.
Who cannot join
- Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.
- Uncontrolled diabetes.
- Use of any systemic or topical drug known to interfere with visual performance.
- Contact lens use during the active treatment portion of the trial.
- Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
- Clinically significant corneal dystrophy.
Show all 19Show fewer
- Irregular astigmatism.
- History of chronic intraocular inflammation.
- History of retinal detachment.
- Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
- Previous intraocular surgery.
- Previous refractive surgery.
- Previous keratoplasty
- Severe dry eye
- Pupil abnormalities
- Subject who may reasonably be expected to require a secondary surgical intervention at any time during the study (other than YAG capsulotomy, i.e. LASIK)
- Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).
- Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.
- Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Carolina Eyecare Physicians, LLC
Mt. Pleasant, South Carolina, 29464
Center for Sight
Sarasota, Florida, 34239
About this study
Official title: Visual Performance and Patient Satisfaction With A New Monofocal Intraocular Lens
This study is a 3-month, prospective, up to 2 center, bilateral, randomized subject masked clinical evaluation of a monofocal intraocular lens (IOL) when both eyes are targeted for emmetropia and when the non-dominant eye is targeted for mini monovision (-0.75 D) in patients with or without astigmatism undergoing routine cataract surgery.
- Conditions
- Cataract, Presbyopia
- Being tested
- Eyhance 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.
Eyhance IOLDevice
Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target emmetropia OU.
Eyhance IOLDevice
Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target mini monovision in the non-dominant eye.
| Study group | Role | What they receive |
|---|---|---|
| Emmetropia | Active comparator | The target refraction for both eyes will be emmetropia (± 0.25 D). Receives: Device: Eyhance IOL |
| Mini monovision | Experimental | The target refraction for the dominant eye will be plano (± 0.25 D) and for the non-dominant eye between -0.75D ±0.15. Receives: Device: Eyhance IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular Distance-corrected Intermediate (66 cm) Visual Acuity at 3 Months.
Measured: 3 months
Secondary outcomes (2)
Binocular Low Contrast Distance Visual Acuity at 3 Months
Measured: 3 months
Distance-corrected Near Visual Acuity at Best Distance at 3 Months
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 posted6 Oct 2021
- Study start4 Oct 2021
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carolina Eyecare Physicians, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kerry D Solomon, Principal investigator, Carolina Eyecare Physicians
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069415
- Sponsor's protocol ID
- CEP 21-001
- Status last verified
- Jan 2024
- First submitted
- 13 Sep 2021
- Last updated
- 13 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Performance and Patient Satisfaction With A New Monofocal Intraocular Lens
- ClinicalTrials.gov ID
- NCT05069415
- Acronym / sponsor ID
- CEP 21-001
- Conditions
- Cataract, Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Carolina Eyecare Physicians, LLCUniversity, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 6 Oct 2021 (actual)
- Results
- Posted 13 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a 3-month, prospective, up to 2 center, bilateral, randomized subject masked clinical evaluation of a monofocal intraocular lens (IOL) when both eyes are targeted for emmetropia and when the non-dominant eye is targeted for mini monovision (-0.75 D) in patients with or without astigmatism undergoing routine cataract surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emmetropia | Active comparator | Device: Eyhance IOLThe target refraction for both eyes will be emmetropia (± 0.25 D). |
| Mini monovision | Experimental | Device: Eyhance IOLThe target refraction for the dominant eye will be plano (± 0.25 D) and for the non-dominant eye between -0.75D ±0.15. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is undergoing bilateral cataract extraction with intraocular lens implantation.
- Willing and able to provide written informed consent for participation in the study
- Willing and able to comply with scheduled visits and other study procedures.
- Scheduled to undergo standard cataract surgery in both eyes within 6 - 30 days between surgeries.
- Subjects who require an IOL power in the range of +5.0 D to +34.0 D only.
Key exclusion criteria (19 listed)
- Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.
- Uncontrolled diabetes.
- Use of any systemic or topical drug known to interfere with visual performance.
- Contact lens use during the active treatment portion of the trial.
- Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
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 |
|---|---|---|
| Eyhance IOLIntraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target emmetropia OU. | Device | Emmetropia, Mini monovision |
| Eyhance IOLIntraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target mini monovision in the non-dominant eye. | Device | Emmetropia, Mini monovision |
Primary outcome
Binocular Distance-corrected Intermediate (66 cm) Visual Acuity at 3 Months.
Time frame: 3 months
2 secondary outcomes
Binocular Low Contrast Distance Visual Acuity at 3 Months
Time frame: 3 months
Distance-corrected Near Visual Acuity at Best Distance at 3 Months
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Kerry D Solomon principal investigator
Carolina Eyecare Physicians
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eyhance IOL in people with Cataract and Presbyopia, run by Carolina Eyecare Physicians, LLC at 2 sites in United States.
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 6 inclusion and 19 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 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 13 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Binocular Distance-corrected Intermediate (66 cm) Visual Acuity at 3 Months. (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 13 Feb 2024.