EyeKon Medical Inc. Capsular Tension Ring Study

Description

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

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Study Overview

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Study Details

Study overview

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.

EyeKon Medical, Inc. Capsular Tension Ring Clinical Study

EyeKon Medical Inc. Capsular Tension Ring Study

Condition
Cataract Extraction
Intervention / Treatment

-

Contacts and Locations

Venice

Stephenson Eye Associates, Venice, Florida, United States, 34285

Washington

Comprehensive Eye Care Ltd., Washington, Missouri, United States, 63090

Lake Jackson

Brazosport Eye Institute, Lake Jackson, Texas, United States, 77566

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

EyeKon Medical, Inc.,

Mark Robinson, STUDY_DIRECTOR, Sponsor/CEO

Study Record Dates

2023-12