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

Carl Zeiss Meditec

Status: Completed

Conditions: Senile Cataract

Study type: Observational

Funder types: Industry

Identifiers

NCT06192901

AT ELANA 841P-BER-401-23

Details and patient eligibility

About

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

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

8 participants in 2 patient groups

Study eye AT ELANA 841P

Description:

Subjects who underwent bilateral cataract surgery with the implantation of the IOL AT ELANA 841P in the first eye.

Study eye AT LISA 839MP

Description:

Subjects who underwent bilateral cataract surgery with the implantation of the IOL AT LISA tri 839MP in the second eye.