MedDataX Logo

Evaluation of Glistening, Visual Outcomes and General Safety 24 Months Post-IOL Implantation

NCT ID: NCT07297719

Last Updated: 2025-12-22

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

NOT_YET_RECRUITING

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-31

Study Completion Date

2026-04-30

Brief Summary

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

Main evaluation of glistening \> 24 Months post-IOL implantation

Detailed Description

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

Evaluation of glistening, visual outcomes and general safety after at least 24 Months post-IOL implantation

Conditions

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

Cataract Senile

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

IOL Glistening

Study Design

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

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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

Inclusion Criteria

1. Patients currently implanted with the CT LUCIA 621P IOL into the capsular bag in at least one eye and who participated in previous study "CT LUCIA 621P-BER-401-21";
2. A minimum follow-up period of 24 months after the IOL implantation of the study eye (selected as the study eye in the previous study);
3. Patients willing and capable of providing informed consent;
4. Patients willing and capable of complying with visits and procedures as defined by this protocol.

Exclusion Criteria

1. Complications during cataract surgery with clinically significant impact;
2. Postoperative clinically significant corneal or retinal pathology as well as postoperative acute or chronic inflammatory ocular conditions (e.g. uveitis, iritis etc.);
3. Presence of clinically significant PCO with potential to limit the glistening evaluation;
4. IOL dislocation (the complete IOL is not stable fixated in the capsular bag);
5. Patients unable to meet the limitations of the protocol or likely of non-cooperation during the clinical investigation;
6. Patients whose freedom is impaired by administrative or legal order.
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.

Aier Eye Hospital of BoAo Hope City

Hainan, , China

Site Status

Countries

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

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Carl Zeiss Meditec AG

Role: CONTACT

Phone: +49308540010

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Study Coordinator

Role: primary

Other Identifiers

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

CT LUCIA 621P-BER-401-25

Identifier Type: -

Identifier Source: org_study_id