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

Senile Cataract Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06192901
• Other study ID #: AT ELANA 841P-BER-401-23
• Status: Completed
• Start date: September 18, 2023
• Est. completion date: September 22, 2023

Study information

• Verified date: September 2023
• Source: Carl Zeiss Meditec AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 22, 2023
• Est. primary completion date: September 22, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Senile Cataract

Locations

Country	Name	City	State
El Salvador	Clinica Quesada	San Salvador

Sponsors (1)

Lead Sponsor	Collaborator
Carl Zeiss Meditec AG

Country where clinical trial is conducted

El Salvador, 

Outcome

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