CataractNCT04059796
Comparison of Gemini III Rev 2 Implanted in Conjunction With an Approved IOL vs Eyes Implanted With an Approved IOL
A study testing Omega Gemini III Rev 2 Device in people with Cataract, run by Omega Ophthalmics at 1 site in Costa Rica.
Trial summary
This study is a prospective, observational, randomized, controlled, paired eye, subject-masked design. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Omega Gemini III Rev 2 Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCosta Rica
- Study dates
- 21 Feb 2020to 28 Aug 2020
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 40 years of age or older at the time of surgery diagnosed with bilateral cataracts
- Able to understand and sign an informed consent
- Willing and able to complete all study visits and assessments required for the study
- Calculated lens power within the available range
- Corrected distance visual acuity is equal to or worse than 20/40 in each eye with or without a glare source present
- Bilateral cataracts eligible for extraction by phacoemulsification and capsular bag fixated IOL implantation
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- Potential postop visual acuity of 20/25 or better in the judgment of the surgeon
- Preoperative corneal astigmatism of 4.0 D or less with normal corneal topography
- Clear intraocular media other than cataract
- Preop endothelial cell density of 2000 cells/mm2 or more
Who cannot join
- Subject's best corrected vision is light perception or no light perception in either eye
- Cataract opacification preventing adequate Binocular Indirect Ophthalmoscopic retinal and macular examination.
- Orbital abnormalities, such as thyroid related orbitopathy, causing significant exophthalmos.
- Eyelid abnormalities causing lagophthalmos.
- Significant anterior blepharitis or meibomian gland dysfunction
- Corneal abnormalities or conditions, other than regular topographic corneal astigmatism
Show all 29Show fewer
- Krukenburg's spindle (linear pigmentary deposits on the corneal endothelium)
- Abnormalities of the iris including trans-illumination defects
- Pupil abnormalities (abnormally shaped, fixed or non-reactive)
- Pharmacologic dilation less than 7 mm
- Axial length <22.5mm
- Lens thickness <4.1 mm
- Anterior chamber depth >2.8mm
- Extremely shallow anterior chamber <2.0mm
- Prior ocular surgery
- Epiretinal membrane
- Macular edema
- Retinal tears including operculated holes
- Amblyopia
- Glaucoma of any kind
- Pseudoexfoliation syndrome
- History of uveitis/iritis
- Diabetic retinopathy
- Acute, chronic or uncontrolled systemic or ocular disease that may confound the results of the study (including rheumatologic conditions such as Rheumatoid arthritis, ankylosing spondyliltis, Sjögren's syndrome, and neurologic conditions such as optic neuritis or multiple sclerosis).
- Prior or anticipated use of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) or similar medications
- Average Keratometry <38D or > 48D by topography
- Any pathology of the zonules including evidence of zonular weakness, zonular instability, zonular damage, or coloboma effecting zonules.
- History of ocular trauma
- Pregnant, lactating, or has another condition with associated fluctuation of hormones that could lead to refractive changes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Investigation of OMEGA Gemini Capsule, Model Gemini Capsule 3 Rev 2 in Combination With a Commercially Available, FDA Approved Monofocal or Toric Intraocular Lens
This study is a prospective, observational, randomized, controlled, paired eye, subject-masked design.
Read the detailed description
Subjects will be randomly assigned to which eye will receive the Omega capsule Gemini 3 with an approved monofocal or Toric intraocular lens. Fellow eyes will receive an approved monofocal or Toric IOL (no Omega capsule).
Eyes randomized to receive one of the Gemini capsules (both models) will be eligible to have a secondary procedure (post 1-month postoperative visit) to correct refractive error.
- Conditions
- Cataract
- Being tested
- Omega Gemini III Rev 2 Device, Control Eye
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega Gemini III Rev 2 DeviceDevice
Eyes randomized to receive the Gemini III Rev 2 device will receive the study device in conjunction with an approved monofocal or toric IOL post cataract extraction
Control EyeDevice
Control eyes will receive an approved monofocal or toric IOL post cataract extraction
| Study group | Role | What they receive |
|---|---|---|
| Study Eye | Experimental | Study device in conjunction with an approved monofocal or toric IOL after cataract extraction Receives: Device: Omega Gemini III Rev 2 Device |
| Control Eye | Active comparator | approved monofocal or toric IOL after cataract extraction Receives: Device: Control Eye |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of fusion of peripheral anterior and posterior capsule to the intraocular lens
Via dilated slit lamp examination subjects will be assessed for anterior and posterior Via dilated slit lamp examination subjects will be assessed for anterior and posterior fusion of the IOL to the capsular bag with a dichotomous "Yes/No" response.
Measured: 6 month Postop Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start21 Feb 2020
- Primary completion28 Aug 2020
- Study completion28 Aug 2020
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omega Ophthalmics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claudio Orlich, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059796
- Sponsor's protocol ID
- Gemini III Rev 2
- Status last verified
- Sep 2020
- First submitted
- 14 Aug 2019
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of OMEGA Gemini Capsule, Model Gemini Capsule 3 Rev 2 in Combination With a Commercially Available, FDA Approved Monofocal or Toric Intraocular Lens
- ClinicalTrials.gov ID
- NCT04059796
- Acronym / sponsor ID
- Gemini III Rev 2
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Omega OphthalmicsIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2020 (actual)
- Primary completion
- 28 Aug 2020 (actual)
- Study completion
- 28 Aug 2020 (actual)
- First posted
- 16 Aug 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 study is a prospective, observational, randomized, controlled, paired eye, subject-masked design.
Detailed description
Subjects will be randomly assigned to which eye will receive the Omega capsule Gemini 3 with an approved monofocal or Toric intraocular lens. Fellow eyes will receive an approved monofocal or Toric IOL (no Omega capsule).
Eyes randomized to receive one of the Gemini capsules (both models) will be eligible to have a secondary procedure (post 1-month postoperative visit) to correct refractive error.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Eye | Experimental | Device: Omega Gemini III Rev 2 DeviceStudy device in conjunction with an approved monofocal or toric IOL after cataract extraction |
| Control Eye | Active comparator | Device: Control Eyeapproved monofocal or toric IOL after cataract extraction |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 40 years of age or older at the time of surgery diagnosed with bilateral cataracts
- Able to understand and sign an informed consent
- Willing and able to complete all study visits and assessments required for the study
- Calculated lens power within the available range
- Corrected distance visual acuity is equal to or worse than 20/40 in each eye with or without a glare source present
Key exclusion criteria (29 listed)
- Subject's best corrected vision is light perception or no light perception in either eye
- Cataract opacification preventing adequate Binocular Indirect Ophthalmoscopic retinal and macular examination.
- Orbital abnormalities, such as thyroid related orbitopathy, causing significant exophthalmos.
- Eyelid abnormalities causing lagophthalmos.
- Significant anterior blepharitis or meibomian gland dysfunction
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 |
|---|---|---|
| Omega Gemini III Rev 2 DeviceEyes randomized to receive the Gemini III Rev 2 device will receive the study device in conjunction with an approved monofocal or toric IOL post cataract extraction | Device | Study Eye |
| Control EyeControl eyes will receive an approved monofocal or toric IOL post cataract extraction | Device | Control Eye |
Primary outcome
Absence of fusion of peripheral anterior and posterior capsule to the intraocular lens
Time frame: 6 month Postop Visit
Via dilated slit lamp examination subjects will be assessed for anterior and posterior Via dilated slit lamp examination subjects will be assessed for anterior and posterior fusion of the IOL to the capsular bag with a dichotomous "Yes/No" response.
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 16 Sep 2020.
- 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.
Claudio Orlich, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega Gemini III Rev 2 Device in people with Cataract, run by Omega Ophthalmics at 1 site in Costa Rica.
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 10 inclusion and 29 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 16 Sep 2020. 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 Costa Rica. 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?
Absence of fusion of peripheral anterior and posterior capsule to the intraocular lens (time frame: 6 month Postop Visit). 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 16 Sep 2020.