EyeKon Medical Inc. Capsular Tension Ring Study
Status unconfirmed · Not applicable
Conditions studied: Cataract Extraction
In brief
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.
Key facts
- Study ID
- NCT02332369
- Run by
- EyeKon Medical, Inc.
- People needed
- 125
- Starts
- 2005-02-01
- Expected to finish
- 2023-12-01
- Last updated by the study team
- 2023-03-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
- 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
Where it is running
- Brazosport Eye Institute — Lake Jackson, Texas, United States (enrolling)
- Stephenson Eye Associates — Venice, Florida, United States
- Comprehensive Eye Care Ltd. — Washington, Missouri, United States
Full record on ClinicalTrials.gov
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