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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06192901

Enrollment

Registered

2024-01-05

Start date

2023-09-18

Completion date

2023-09-22

Last updated

2024-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Senile Cataract

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Countries

El Salvador

Outcome results