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

N/ACompletedNCT06192901

Carl Zeiss Meditec AG8 enrolled

Overview

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

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

Conditions

Senile Cataract

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Clinica Quesada

San Salvador, El Salvador

Outcomes

Primary Outcomes

Monocular Corrected Distance Visual Acuity (CDVA)

Time frame: 12 to 24 months after cataract surgery

Slit Lamp Examination

Time frame: 12 to 24 months after cataract surgery

Data from ClinicalTrials.gov

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