EyeKon Medical Inc. Capsular Tension Ring Study

Last updated: March 10, 2023
Sponsor: EyeKon Medical, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Eye Disorders/infections

Vision Loss

Eye Disease

Treatment

N/A

Clinical Study ID

NCT02332369
EyeKon CTR--01
  • Ages > 18
  • All Genders

Study 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. 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The patient is in good general and ocular health, having a vision-reducing cataract inthe intended operative eye.
  • The intended operative eye has a Snellen best corrected visual of 20/40 or worse fordistance 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 compromisedzonules (torn or missing estimated not to exceed one-third of the capsular bagdiameter) due to Pseudoexfoliation Syndrome, Marfans Syndrome, trauma or other zonularcompromising condition.
  • The capsule is intact during insertion.

Exclusion

Exclusion Criteria:

  • Only one functional eye
  • Capsular bag tearing beyond the point where the surgeon thinks it is in the bestinterest 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 thepatient or the accuracy of the study

Study Design

Total Participants: 125
Study Start date:
February 01, 2005
Estimated Completion Date:
December 31, 2023

Study Description

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.

Connect with a study center

  • Stephenson Eye Associates

    Venice, Florida 34285
    United States

    Completed

  • Comprehensive Eye Care Ltd.

    Washington, Missouri 63090
    United States

    Completed

  • Eye Care Associates of South Tulsa

    Tulsa, Oklahoma 74133
    United States

    Site Not Available

  • Brazosport Eye Institute

    Lake Jackson, Texas 77566
    United States

    Active - Recruiting

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