CTR: EyeKon Medical Inc. Capsular Tension Ring Study

Sponsor
EyeKon Medical, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT02332369
Collaborator
(none)
125
3
1
225.9
41.7
0.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Capsular Tension Ring
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
125 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
EyeKon Medical, Inc. Capsular Tension Ring Clinical Study
Actual Study Start Date :
Feb 1, 2005
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Device

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

Outcome Measures

Primary Outcome Measures

  1. Visual Acuity [At all pre/post op CFR's for 1 year.]

    Best case visual acuity at 1 year of follow-up based upon LogMar score.

Secondary Outcome Measures

  1. Adverse Events [1 Year]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stephenson Eye Associates Venice Florida United States 34285
2 Comprehensive Eye Care Ltd. Washington Missouri United States 63090
3 Brazosport Eye Institute Lake Jackson Texas United States 77566

Sponsors and Collaborators

  • EyeKon Medical, Inc.

Investigators

  • Study Director: Mark Robinson, Sponsor/CEO

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
EyeKon Medical, Inc.
ClinicalTrials.gov Identifier:
NCT02332369
Other Study ID Numbers:
  • EyeKon CTR--01
First Posted:
Jan 6, 2015
Last Update Posted:
Jun 18, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by EyeKon Medical, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 18, 2021