Lake Jackson, Texas 77566

  • Cataract Extraction

Purpose:

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.


Study summary:

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.


Criteria:

Inclusion 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. Exclusion Criteria: - 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


Study is Available At:


Original ID:

EyeKon CTR--01


NCT ID:

NCT02332369


Secondary ID:


Study Acronym:

CTR


Brief Title:

EyeKon Medical Inc. Capsular Tension Ring Study


Official Title:

EyeKon Medical, Inc. Capsular Tension Ring Clinical Study


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

EyeKon Medical, Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

125


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Mark Robinson
Study Director
Sponsor/CEO
Primary Contact:Barry L Bowyer, MSPH
7277930170
barry@eyekonmedical.com
Backup Contact:Mark Robinson
7277930170
Mark@eyekonmedical.com

Study Dates

Start Date:February 2005
Completion Date:December 2023
Completion Type:Anticipated
Primary Completion Date:December 2023
Primary Completion Type:Anticipated
Verification Date:February 2021
Last Changed Date:February 12, 2021
First Received Date:January 5, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Adverse Events
Time Frame:1 Year
Safety Issues:False
Description:Adverse events will be compared to the FDA historical grid and must be less than or equal to those shown in the grid on a percentage of patients enrolled basis.
Outcome Type:Primary Outcome
Measure:Visual Acuity
Time Frame:At all pre/post op CFR's for 1 year.
Safety Issues:False
Description:Best case visual acuity at 1 year of follow-up based upon LogMar score.

Study Interventions

Intervention Type:Device
Name:Capsular Tension Ring
Arm Name:Device

Study Arms

Study Arm Type:Experimental
Arm Name:Device
Description:Polymethylmethacrylate Capsular Tension Ring introduced into the posterior chamber of the eye following cataract surgery before the implantation of an intraocular lens.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:EyeKon Medical, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 16, 2021

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