EyeKon Medical Inc. Capsular Tension Ring Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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EyeKon Medical, Inc. Capsular Tension Ring Clinical Study

Conditions
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Cataract Extraction

Intervention / Treatment
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* Device: Capsular Tension Ring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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. Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device<br>Polymethylmethacrylate Capsular Tension Ring introduced into the posterior chamber of the eye following cataract surgery before the implantation of an intraocular lens. | Device: Capsular Tension Ring<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Best case visual acuity at 1 year of follow-up based upon LogMar score. | At all pre/post op CFR's for 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract