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Artisan Aphakia Lens for the Correction of Aphakia (Secondary) in Adults

Sponsor
Ophtec USA (Industry)
Overall Status
Recruiting
CT.gov ID
NCT01547429
Collaborator
(none)
300
Enrollment
16
Locations
1
Arm
167
Duration (Months)
18.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will determine the safety and effectiveness of the Artisan Aphakia Lens when used as a secondary implant to correct aphakia in adults.

Condition or Disease Intervention/Treatment Phase
  • Device: Artisan Aphakia Intraocular Lens
 N/A

Detailed Description

Not desired

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Artisan Aphakia Lens for the Correction of Aphakia in Adults
Study Start Date :
Jan 1, 2012
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intraocular Lens Implantation for the Treatment for Aphakia

Implantation of an Artisan intraocular lens to correct aphakia in Adults. No other information is needed to describe this section

Device: Artisan Aphakia Intraocular Lens
Implantation of lens to correct refractive error in aphakic eye

Outcome Measures

Primary Outcome Measures

  1. Improvement in best corrected visual acuity [3 year follow up]

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Patients 22 years of age and over at baseline visit of either sex and of any race where the natural lens has been removed or will be removed and a posterior chamber IOL is not indicated.

  • Patient must agree to comply with the visit schedule and other requirements of the study

Exclusion Criteria:

  • Patients that are not able to meet the extensive postoperative evaluation requirements

  • Mentally retarded patients

  • When the patient has no useful vision or vision potential in the fellow eye

  • History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.), corneal dystrophy, degeneration, opacities or abnormalities that may affect vision.

  • Abnormality of the iris or ocular structure which would preclude fixation, such as aniridia, hemiiridectomy, severe iris atrophy, rubeosis iridis, or other compromising iris pathology

  • Patients with uncontrolled glaucoma

  • High preoperative intraocular pressure, >25 mmHg

  • Chronic or recurrent uveitis or history of the same

  • Preexisting macular pathology that may complicate the ability to assess the benefit or lack of benefit obtained by the lens

  • Patients with a retinal detachment or a family history of retinal detachment

  • Retinal disease that may limit the visual potential of the eye such as retinopathy of prematurity or Stargardt's retinopathy Optic nerve disease that may limit the visual potential of the eye

  • Diabetes mellitus

  • Pregnant, lactating, or plans to become pregnant during the course of this study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assil Eye Institute Beverly Hills California United States 90210
2 Advanced Vision Care Los Angeles California United States 90067
3 Yale Medicine Ophthalmology Stratford Connecticut United States 06614
4 Price Vision Group Indianapolis Indiana United States 46260
5 John Kenyon Eye Center Jeffersonville Indiana United States 47130
6 Boston Children's Hospital Boston Massachusetts United States 02115
7 Rosenthal Eye and Facial Plastic Surgery Great Neck New York United States 11023
8 Pamel Vision and Laser Group New York New York United States 10065
9 New York Medical College, Westchester Medical Center Valhalla New York United States 10595
10 Nevyas Eye Associates Bala-Cynwyd Pennsylvania United States 19004
11 Vance Thompson Vision Sioux Falls South Dakota United States 57108
12 University of Tennessee, Hamilton Eye Clinic Memphis Tennessee United States 38163
13 Focal Point Vision San Antonio Texas United States 78229
14 Moran Eye Center Salt Lake City Utah United States 84132
15 Valley Eye Associates Appleton Wisconsin United States 54914
16 Prism Eye Institute Mississauga Ontario Canada L5L 1W8

Sponsors and Collaborators

  • Ophtec USA

Investigators

  • Study Director: Abraham Farhan, Sponsor GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ophtec USA
ClinicalTrials.gov Identifier:
NCT01547429
Other Study ID Numbers:
  • Artisan Adult Aphakia
First Posted:
Mar 7, 2012
Last Update Posted:
Jun 27, 2022
Last Verified:
Jun 1, 2022
Keywords provided by Ophtec USA
aphakia
secondary intraocular lens
Additional relevant MeSH terms:
Aphakia

Study Results

No Results Posted as of Jun 27, 2022