Safety and Performance of Hydrophobic and Hydrophilic Intraocular Lenses After Bilateral Cataract Surgery

December 20, 2023 updated by: Carl Zeiss Meditec AG

A Limited Patient Cohort Follow-up Study to Assess the Long-term Safety and Performance of Hydrophobic and Hydrophilic Intraocular Lenses in Bilateral Cataract Surgery

Subjects who had a bilateral age-related cataract surgery with the IOLs AT ELANA 841P and AT LISA tri 839MP will be contacted and invited to attend a postoperative visit more than one year after the surgery

Study Overview

Status

Completed

Conditions

Detailed Description

The main objective of this clinical investigation is to collect data on the IOLs AT ELANA 841P and AT LISA tri 839MP in subjects who underwent bilateral cataract surgery with the use of the two different types of IOLs to confirm the long-term performance and safety of the IOLs.

Retro-prospective, comparative, non-interventional, non-randomized, single center study on medical devices with one follow-up visit after more than 12 months of a bilateral cataract surgery.Subjects who had a bilateral age-related cataract surgery with the IOLs AT ELANA 841P and AT LISA tri 839MP will be contacted and invited to attend a postoperative visit more than one year after the surgery.

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • El Salvador
      • San Salvador, El Salvador
        • Clinica Quesada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Up to 20 eyes in 10 adult subjects who underwent bilateral cataract surgery with the implantation of the IOL AT ELANA 841P in the first eye and AT LISA tri 839MP in the second eye.

Description

Inclusion Criteria:

  1. Adult patient of any gender;
  2. Patients who had an uncomplicated (no intra-operative complication) age-related cataract surgery
  3. Currently implanted with an IOL model AT ELANA 841P into the capsular bag in one eye and with the IOL model AT LISA tri 839MP into the capsular bag of the other eye.
  4. The postoperative visit was scheduled to be conducted more than one year after the second eye surgery.
  5. Given written informed consent by patient.

Exclusion Criteria:

  1. Patients unable to meet the limitations of the protocol or likely of non-cooperation during the study
  2. Patient whose freedom is impaired by administrative or legal order
  3. Concurrent participation in another drug or device investigation that could confound the outcome of this investigation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Study eye AT ELANA 841P
Subjects who underwent bilateral cataract surgery with the implantation of the IOL AT ELANA 841P in the first eye.
Study eye AT LISA 839MP
Subjects who underwent bilateral cataract surgery with the implantation of the IOL AT LISA tri 839MP in the second eye.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Monocular Corrected Distance Visual Acuity (CDVA)
Time Frame: 12 to 24 months after cataract surgery
12 to 24 months after cataract surgery
Slit Lamp Examination
Time Frame: 12 to 24 months after cataract surgery
12 to 24 months after cataract surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carl Zeiss Meditec AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2023

Primary Completion (Actual)

September 22, 2023

Study Completion (Actual)

September 22, 2023

Study Registration Dates

First Submitted

September 12, 2023

First Submitted That Met QC Criteria

December 20, 2023

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

December 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AT ELANA 841P-BER-401-23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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