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

NCT ID: NCT06192901

Last Updated: 2024-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-18

Study Completion Date

2023-09-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Senile Cataract

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study eye AT ELANA 841P

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

No interventions assigned to this group

Study eye AT LISA 839MP

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Carl Zeiss Meditec AG

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinica Quesada

San Salvador, , El Salvador

Site Status

Countries

Review the countries where the study has at least one active or historical site.

El Salvador

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AT ELANA 841P-BER-401-23

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Evaluation of a Trifocal Lens
NCT04545671 COMPLETED
Combined EDOF / Trifocal
NCT05462067 COMPLETED NA