Recruiting

Capsular Tension Ring

Sponsor:

EyeKon Medical, Inc.

Code:

NCT02332369

Conditions

Cataract Extraction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Capsular Tension Ring

Study Details

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

Study ID

NCT02332369

Start date

Feb, 2005

Status verified date

Mar, 2023

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

125 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Device

Polymethylmethacrylate Capsular Tension Ring introduced into the posterior chamber of the eye following cataract surgery before the implantation of an intraocular lens.

Interventions

Capsular Tension Ring

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Barry L Bowyer, MSPH

7277930170barry@eyekonmedical.com

Mark Robinson

7277930170Mark@eyekonmedical.com

Locations

Brazosport Eye Institute

Recruiting

Lake Jackson, Texas, United States, 77566

Contacts

Christian Penland

ljm.christianp@gmail.com

Principal Investigator:

Jonathan Grady, MD

More Information

Sponsor

EyeKon Medical, Inc.

Last update posted

Mar 13, 2023

Last verified

Mar, 2023

Keywords

  • Cataract

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by EyeKon Medical, Inc. on 2023-03-13.