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Completed

NCT Number: NCT06192901

Safety and Performance of Hydrophobic and Hydrophilic Intraocular Lenses After 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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinica Quesada

San Salvador, El Salvador

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patient of any gender;
  • Patients who had an uncomplicated (no intra-operative complication) age-related cataract surgery
  • 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.
  • The postoperative visit was scheduled to be conducted more than one year after the second eye surgery.
  • Given written informed consent by patient.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Monocular Corrected Distance Visual Acuity (CDVA)

    Time frame: 12 to 24 months after cataract surgery

  2. Slit Lamp Examination

    Time frame: 12 to 24 months after cataract surgery

Sponsors and collaborators

Lead sponsor

Carl Zeiss Meditec AG

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 5, 2024
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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