UVEA509: Clinical Safety and Efficacy of CT ASPHINA 509 Lenses

• Sponsor: Carl Zeiss Meditec AG (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03145116
• Collaborator: (none)
• Enrollment: 95
• Location: 1
• Arm: 1
• Actual Duration (Months): 4.5
• Patients Per Site Per Month: 21.3

Study Details

Study Description

Brief Summary

Clinical safety and efficacy of CT ASPHINA 509 IOLs after implantation

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: CT ASPHINA 509	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 95 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Safety and Efficacy of Hydrophilic Acrylic Intraocular Lenses - Retro Prospective Study
• Actual Study Start Date: Sep 22, 2017
• Actual Primary Completion Date: Feb 5, 2018
• Actual Study Completion Date: Feb 5, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 509	Device: CT ASPHINA 509; Intraocular lens

Outcome Measures

Primary Outcome Measures

1. Visual acuity [12 to 18 months after surgery]

   Monocular best corrected distance visual acuity

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent;

• Patients of any gender

• Assured follow-up examinations

• Biometry measurement preferably compatible with the IOLMaster evaluation;

• IOL implanted into the capsular bag with IOL model CT ASPHINA 409MP (UVE material) in one eye with at least 12 months follow up at the time of the postop visit

• Patients who had uncomplicated (no peroperative complication) agedrelated cataract surgery in a healthy eye (beside clinically significant cataract)

Exclusion Criteria:

• • BCVA not available preoperatively or better than 0.3 logMAR pre-op

• Patients unable to meet the limitations of the protocol or likely of noncooperation during the trial

• Patients whose freedom is impaired by administrative or legal order

• Concurrent participation in another drug or device investigation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Augenklinink	Ahaus		Germany	12593

Sponsors and Collaborators

• Carl Zeiss Meditec AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Carl Zeiss Meditec AG
• ClinicalTrials.gov Identifier: NCT03145116
• Other Study ID Numbers: ASPHINA 509-BER-401-17
• First Posted: May 9, 2017
• Last Update Posted: Jul 18, 2018
• Last Verified: Jan 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Jul 18, 2018