EyeKon Medical Inc. Capsular Tension Ring Study
EyeKon Medical Inc. Capsular Tension Ring 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.
The clinical study of the CTR-10 and CTR-12 Capsular Tension Rings is to be conducted with
 the following objectives:

 1. Determine the ability of the device to maintain the shape of the capsular bag and
 therefore keep the intraocular lens centered;

 2. Determine post-operative visual acuity of patients receiving the capsular tension ring
 as a secondary method of determining the efficacy;

 3. Describe the occurrence and time course of postoperative complications and adverse
 reactions for capsular tension ring implant subjects;

 4. Describe the occurrence of postoperative complications for the implant group and their
 relationship to ocular complications.

 5. Identify groups within the implant study population that are at "high risk" of
 particular complications.

 6. Collect and analyze against those historical controls published by FDA data on:

 1. Overall Visual Acuity

 2. Best Case Visual Acuity

 3. Cumulative Hyphema

 4. Cumulative Macular Edema

 5. Cumulative Retinal Detachment

 6. Cumulative Pupillary Block

 7. Cumulative Lens Dislocation

 8. Cumulative Endophthalmitis

 9. Cumulative Hypopyon

 10. Cumulative Surgical Reintervention

 11. Persistent Macular Edema

 12. Persistent Corneal Edema

 13. Persistent Iritis

 14. Persistent Raised IOP Requiring treatment

 15. 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.
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