EyeKon Medical Inc. Capsular Tension Ring Study (CTR)
-
- STATUS
- Recruiting
-
- End date
- Dec 25, 2023
-
- participants needed
- 125
-
- sponsor
- EyeKon Medical, Inc.
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.
Description
The clinical study of the CTR-10 and CTR-12 Capsular Tension Rings is to be conducted with the following objectives:
- Determine the ability of the device to maintain the shape of the capsular bag and therefore keep the intraocular lens centered;
- Determine post-operative visual acuity of patients receiving the capsular tension ring as a secondary method of determining the efficacy;
- Describe the occurrence and time course of postoperative complications and adverse reactions for capsular tension ring implant subjects;
- Describe the occurrence of postoperative complications for the implant group and their relationship to ocular complications.
- Identify groups within the implant study population that are at "high risk" of particular complications.
- Collect and analyze against those historical controls published by FDA data on:
- Overall Visual Acuity
- Best Case Visual Acuity
- Cumulative Hyphema
- Cumulative Macular Edema
- Cumulative Retinal Detachment
- Cumulative Pupillary Block
- Cumulative Lens Dislocation
- Cumulative Endophthalmitis
- Cumulative Hypopyon
- Cumulative Surgical Reintervention
- Persistent Macular Edema
- Persistent Corneal Edema
- Persistent Iritis
- Persistent Raised IOP Requiring treatment
- Frequency and degree of posterior capsule opacification
The investigational plan for the clinical study of capsular tension rings is designed to satisfy the requirements of the Investigational Device Exemption (IDE) regulations, which require a well-controlled clinical trial with ongoing monitoring to evaluate the safety and efficacy of the intraocular lenses.
The study will consist of adult patients who will be enrolled into the study. The results of these implants will be carefully monitored for approximately twelve (12) months.
Details
| Condition | Cataract Extraction |
|---|---|
| Treatment | Capsular Tension Ring |
| Clinical Study Identifier | NCT02332369 |
| Sponsor | EyeKon Medical, Inc. |
| Last Modified on | 24 January 2022 |
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Browse trials for
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer