EyeKon Medical Inc. Capsular Tension Ring Study (CTR)

  • STATUS
    Recruiting
  • End date
    Dec 25, 2023
  • participants needed
    125
  • sponsor
    EyeKon Medical, Inc.
Updated on 24 January 2022
intraocular lens implantation
glare
after cataract
marfans syndrome

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.

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:
  7. Overall Visual Acuity
  8. Best Case Visual Acuity
  9. Cumulative Hyphema
  10. Cumulative Macular Edema
  11. Cumulative Retinal Detachment
  12. Cumulative Pupillary Block
  13. Cumulative Lens Dislocation
  14. Cumulative Endophthalmitis
  15. Cumulative Hypopyon
  16. Cumulative Surgical Reintervention
  17. Persistent Macular Edema
  18. Persistent Corneal Edema
  19. Persistent Iritis
  20. Persistent Raised IOP Requiring treatment
  21. 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.

Details
Condition Cataract Extraction
Treatment Capsular Tension Ring
Clinical Study IdentifierNCT02332369
SponsorEyeKon Medical, Inc.
Last Modified on24 January 2022

Eligibility

Yes No Not Sure

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
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