Cataract ExtractionCTRNCT02332369
EyeKon Medical Inc. Capsular Tension Ring Study
A study testing Capsular Tension Ring in people with Cataract Extraction, run by EyeKon Medical, Inc. at 3 sites in United States.
Trial summary
This study evaluates the safety and effectiveness of a capsular tension ring (CTR) when used during cataract surgery. Capsular Tension Rings are used during intraocular lens implantation to give added support in order to keep the intraocular lens well centered, especially in eyes with weak or partially absent zonules. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract Extraction
- What is being tested?
- Capsular Tension Ring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2005to Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is in good general and ocular health, having a vision-reducing cataract in the intended operative eye.
- The intended operative eye has a Snellen best corrected visual of 20/40 or worse for distance or the refraction worsens to this level with glare testing.
- The patients' worse seeing Eye is 20/70 or better.
- The patient is willing and able to complete all required postoperative visits.
- The patient is willing to sign a statement of informed consent.
- The patient is at least 21 years old.
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- The patient requires cataract surgery with IOL implantation.
- The patient has observed or suspected weakened, torn, missing or otherwise compromised zonules (torn or missing estimated not to exceed one-third of the capsular bag diameter) due to Pseudoexfoliation Syndrome, Marfans Syndrome, trauma or other zonular compromising condition.
- The capsule is intact during insertion.
Who cannot join
- Only one functional eye
- Capsular bag tearing beyond the point where the surgeon thinks it is in the best interest of the patient to have a capsular ring implanted
- Significant zonular didlysis during surgery
- Preoperative ocular infection
- Ocular inflammation or uveitis
- Amblyopia
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- Aniridia
- Congenital cataracts
- Cataracts due to rubella
- Corneal disease
- Diabetes
- Preoperative intraocular pressure over 21 mm Hg
- Iritis
- Iris atrophy
- Pseudophakic lens exchange
- Microphthalmia
- Optic atrophy
- Macular degeneration
- Retinal detachment
- Retinal degeneration
- Vitritis
- Flat anterior chamber
- Other conditions as noted by the surgeon which may compromise the safety of the patient or the accuracy of the study
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 1 recruiting
- Recruiting
Brazosport Eye Institute
Lake Jackson, Texas, 77566
Christian Penland, ljm.christianp@gmail.com
Jonathan Grady, MD
- Completed
Stephenson Eye Associates
Venice, Florida, 34285
- Completed
Comprehensive Eye Care Ltd.
Washington, Missouri, 63090
About this study
Official title: EyeKon Medical, Inc. Capsular Tension Ring Clinical Study
This study evaluates the safety and effectiveness of a capsular tension ring (CTR) when used during cataract surgery. Capsular Tension Rings are used during intraocular lens implantation to give added support in order to keep the intraocular lens well centered, especially in eyes with weak or partially absent zonules. In many cases, capsular tension rings allow a lens to be successfully implanted into an eye which otherwise could not have supported an intraocular lens.
Read the detailed description
The clinical study of the CTR-10 and CTR-12 Capsular Tension Rings is to be conducted with the following objectives:
- Determine the ability of the device to maintain the shape of the capsular bag and therefore keep the intraocular lens centered;
- Determine post-operative visual acuity of patients receiving the capsular tension ring as a secondary method of determining the efficacy;
- Describe the occurrence and time course of postoperative complications and adverse reactions for capsular tension ring implant subjects;
- Describe the occurrence of postoperative complications for the implant group and their relationship to ocular complications.
- Identify groups within the implant study population that are at "high risk" of particular complications.
- Collect and analyze against those historical controls published by FDA data on:
- Overall Visual Acuity
- Best Case Visual Acuity
- Cumulative Hyphema
- Cumulative Macular Edema
- Cumulative Retinal Detachment
- Cumulative Pupillary Block
- Cumulative Lens Dislocation
- Cumulative Endophthalmitis
- Cumulative Hypopyon
- Cumulative Surgical Reintervention
- Persistent Macular Edema
- Persistent Corneal Edema
- Persistent Iritis
- Persistent Raised IOP Requiring treatment
- Frequency and degree of posterior capsule opacification
The investigational plan for the clinical study of capsular tension rings is designed to satisfy the requirements of the Investigational Device Exemption (IDE) regulations, which require a well-controlled clinical trial with ongoing monitoring to evaluate the safety and efficacy of the intraocular lenses.
The study will consist of adult patients who will be enrolled into the study. The results of these implants will be carefully monitored for approximately twelve (12) months.
- Conditions
- Cataract Extraction
- Being tested
- Capsular Tension Ring
- Keywords
- Cataract
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsular Tension RingDevice
| Study group | Role | What they receive |
|---|---|---|
| Device | Experimental | Polymethylmethacrylate Capsular Tension Ring introduced into the posterior chamber of the eye following cataract surgery before the implantation of an intraocular lens. Receives: Device: Capsular Tension Ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Best case visual acuity at 1 year of follow-up based upon LogMar score.
Measured: At all pre/post op CFR's for 1 year.
Secondary outcomes (1)
Adverse Events
Adverse events will be compared to the FDA historical grid and must be less than or equal to those shown in the grid on a percentage of patients enrolled basis.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startFeb 2005
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract ExtractionStudies 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
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EyeKon Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Robinson, Study director, Sponsor/CEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332369
- Sponsor's protocol ID
- EyeKon CTR--01
- Acronym
- CTR
- Status last verified
- Mar 2023
- First submitted
- 5 Jan 2015
- Last updated
- 13 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EyeKon Medical, Inc. Capsular Tension Ring Clinical Study
- ClinicalTrials.gov ID
- NCT02332369
- Acronym / sponsor ID
- CTR / EyeKon CTR--01
- Conditions
- Cataract Extraction
- Keywords
- Cataract
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- EyeKon Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2005 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 6 Jan 2015 (estimated)
- 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 evaluates the safety and effectiveness of a capsular tension ring (CTR) when used during cataract surgery. Capsular Tension Rings are used during intraocular lens implantation to give added support in order to keep the intraocular lens well centered, especially in eyes with weak or partially absent zonules. In many cases, capsular tension rings allow a lens to be successfully implanted into an eye which otherwise could not have supported an intraocular lens.
Detailed description
The clinical study of the CTR-10 and CTR-12 Capsular Tension Rings is to be conducted with the following objectives:
- Determine the ability of the device to maintain the shape of the capsular bag and therefore keep the intraocular lens centered;
- Determine post-operative visual acuity of patients receiving the capsular tension ring as a secondary method of determining the efficacy;
- Describe the occurrence and time course of postoperative complications and adverse reactions for capsular tension ring implant subjects;
- Describe the occurrence of postoperative complications for the implant group and their relationship to ocular complications.
- Identify groups within the implant study population that are at "high risk" of particular complications.
- Collect and analyze against those historical controls published by FDA data on:
- Overall Visual Acuity
- Best Case Visual Acuity
- Cumulative Hyphema
- Cumulative Macular Edema
- Cumulative Retinal Detachment
- Cumulative Pupillary Block
- Cumulative Lens Dislocation
- Cumulative Endophthalmitis
- Cumulative Hypopyon
- Cumulative Surgical Reintervention
- Persistent Macular Edema
- Persistent Corneal Edema
- Persistent Iritis
- Persistent Raised IOP Requiring treatment
- Frequency and degree of posterior capsule opacification
The investigational plan for the clinical study of capsular tension rings is designed to satisfy the requirements of the Investigational Device Exemption (IDE) regulations, which require a well-controlled clinical trial with ongoing monitoring to evaluate the safety and efficacy of the intraocular lenses.
The study will consist of adult patients who will be enrolled into the study. The results of these implants will be carefully monitored for approximately twelve (12) months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device | Experimental | Device: Capsular Tension RingPolymethylmethacrylate Capsular Tension Ring introduced into the posterior chamber of the eye following cataract surgery before the implantation of an intraocular lens. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patient is in good general and ocular health, having a vision-reducing cataract in the intended operative eye.
- The intended operative eye has a Snellen best corrected visual of 20/40 or worse for distance or the refraction worsens to this level with glare testing.
- The patients' worse seeing Eye is 20/70 or better.
- The patient is willing and able to complete all required postoperative visits.
- The patient is willing to sign a statement of informed consent.
Key exclusion criteria (23 listed)
- Only one functional eye
- Capsular bag tearing beyond the point where the surgeon thinks it is in the best interest of the patient to have a capsular ring implanted
- Significant zonular didlysis during surgery
- Preoperative ocular infection
- Ocular inflammation 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 |
|---|---|---|
| Capsular Tension Ring | Device | Device |
Primary outcome
Visual Acuity
Time frame: At all pre/post op CFR's for 1 year.
Best case visual acuity at 1 year of follow-up based upon LogMar score.
1 secondary outcome
Adverse Events
Time frame: 1 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
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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.
Mark Robinson study director
Sponsor/CEO
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capsular Tension Ring in people with Cataract Extraction, run by EyeKon Medical, Inc. at 3 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 9 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barry L Bowyer, MSPH (7277930170, barry@eyekonmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity (time frame: At all pre/post op CFR's for 1 year.). 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 Mar 2023.