NCT02332369

EyeKon Medical Inc. Capsular Tension Ring Study

EyeKon Medical, Inc. Capsular Tension Ring Clinical Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: EyeKon Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The clinical study of the CTR-10 and CTR-12 Capsular Tension Rings is to be conducted with the following objectives: 1. Determine the ability of the device to maintain the shape of the capsular bag and therefore keep the intraocular lens centered; 2. Determine post-operative visual acuity of patients receiving the capsular tension ring as a secondary method of determining the efficacy; 3. Describe the occurrence and time course of postoperative complications and adverse reactions for capsular tension ring implant subjects; 4. Describe the occurrence of postoperative complications for the implant group and their relationship to ocular complications. 5. Identify groups within the implant study population that are at "high risk" of particular complications. 6. Collect and analyze against those historical controls published by FDA data on: 1. Overall Visual Acuity 2. Best Case Visual Acuity 3. Cumulative Hyphema 4. Cumulative Macular Edema 5. Cumulative Retinal Detachment 6. Cumulative Pupillary Block 7. Cumulative Lens Dislocation 8. Cumulative Endophthalmitis 9. Cumulative Hypopyon 10. Cumulative Surgical Reintervention 11. Persistent Macular Edema 12. Persistent Corneal Edema 13. Persistent Iritis 14. Persistent Raised IOP Requiring treatment 15. 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.

Conditions

• Cataract Extraction

Interventions

Type	Name	Description
DEVICE	Capsular Tension Ring

Timeline

• Start date: 2005-02-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2015-01-06
• Last updated: 2023-03-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study