EyeKon Medical Inc. Capsular Tension Ring Study

NCT02332369 | Unknown FDA Device

• 1 other identifier: EyeKon CTR--01
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 3

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.

Conditions

Cataract Extraction

Keywords

Cataract

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse Events

  1 Year

Study Arms (1)

Device

EXPERIMENTAL

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

Interventions

Capsular Tension Ring DEVICE

Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• EyeKon Medical, Inc.: lead

Study Sites (3)

Stephenson Eye Associates

Venice, Florida, 34285, United States

COMPLETED

Comprehensive Eye Care Ltd.

Washington, Missouri, 63090, United States

COMPLETED

Brazosport Eye Institute

Lake Jackson, Texas, 77566, United States

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Mark Robinson

  Sponsor/CEO

  STUDY DIRECTOR

Central Study Contacts

Barry L Bowyer, MSPH

CONTACT

7277930170; barry@eyekonmedical.com

Mark Robinson

CONTACT

7277930170; Mark@eyekonmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2015
• First Posted: January 6, 2015
• Study Start: February 1, 2005
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 13, 2023

Record last verified: 2023-03

Locations

US (3)