RECRUITING

EyeKon Medical Inc. Capsular Tension Ring Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

EyeKon Medical, Inc. Capsular Tension Ring Clinical Study

Quick Facts

Study Start:2005-02
Study Completion:2023-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02332369

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * The patient is in good general and ocular health, having a vision-reducing cataract in the intended operative eye.
  2. * 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.
  3. * The patients' worse seeing Eye is 20/70 or better.
  4. * The patient is willing and able to complete all required postoperative visits.
  5. * The patient is willing to sign a statement of informed consent.
  6. * The patient is at least 21 years old.
  7. * The patient requires cataract surgery with IOL implantation.
  8. * 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.
  9. * The capsule is intact during insertion.
  1. * Only one functional eye
  2. * 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
  3. * Significant zonular didlysis during surgery
  4. * Preoperative ocular infection
  5. * Ocular inflammation or uveitis
  6. * Amblyopia
  7. * Aniridia
  8. * Congenital cataracts
  9. * Cataracts due to rubella
  10. * Corneal disease
  11. * Diabetes
  12. * Preoperative intraocular pressure over 21 mm Hg
  13. * Iritis
  14. * Iris atrophy
  15. * Pseudophakic lens exchange
  16. * Microphthalmia
  17. * Optic atrophy
  18. * Macular degeneration
  19. * Retinal detachment
  20. * Retinal degeneration
  21. * Vitritis
  22. * Flat anterior chamber
  23. * Other conditions as noted by the surgeon which may compromise the safety of the patient or the accuracy of the study

Contacts and Locations

Study Contact

Barry L Bowyer, MSPH
CONTACT
7277930170
barry@eyekonmedical.com
Mark Robinson
CONTACT
7277930170
Mark@eyekonmedical.com

Principal Investigator

Mark Robinson
STUDY_DIRECTOR
Sponsor/CEO

Study Locations (Sites)

Stephenson Eye Associates
Venice, Florida, 34285
United States
Comprehensive Eye Care Ltd.
Washington, Missouri, 63090
United States
Brazosport Eye Institute
Lake Jackson, Texas, 77566
United States

Collaborators and Investigators

Sponsor: EyeKon Medical, Inc.

  • Mark Robinson, STUDY_DIRECTOR, Sponsor/CEO

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2005-02
Study Completion Date2023-12

Study Record Updates

Study Start Date2005-02
Study Completion Date2023-12

Terms related to this study

Keywords Provided by Researchers

  • Cataract

Additional Relevant MeSH Terms

  • Cataract Extraction