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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Study population: Patients currently implanted with the CT LUCIA 621P IOL from the Aier Eye Hospital of BoAo Hope City

Trial locations and contacts

1 site in 1 country.

About this study

Official title: A Non-interventional, Single-visit Study Focusing on the Evaluation of Glistening as Well as General Safety and Visual Outcomes With at Least 24 Months Follow-up in Patients Implanted With CT LUCIA 621P Intraocular Lenses

Conditions

Cataract Senile

Keywords

IOL, Glistening

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Glistening Count

   Glistening count: Number of glistenings (=microvacuoles) in the illuminated field were counted by slit lamp examination at the study visit 24 months post IOL implantation of the study eye. Lower glistening counts indicate a better outcome (=fewer glistenings).

   Measured: single study visit conducted 24 months after IOL implantation of the study eye

2. Glistening Density Evaluation

   Glistening density evaluation: Number of glistenings in the illuminated field were counted by slit lamp examination at the study visit 24 months post IOL implantation of the study eye. The number of glistenings were recorded and the density of microvacuoles per square millimeter (MV/mm²) was calculated. Lower glistening density values indicate better outcome (=fewer glistenings).

   Measured: single study visit conducted 24 months after IOL implantation of the study eye

3. Glistening Grading (Miyata Classification)

   Glistening grading (Miyata classification): At the 24-month post-IOL implantation visit, the number of glistenings/microvacuoles (MV) in the illuminated field of the study eye was counted by slit-lamp examination. Glistening density was expressed as microvacuoles per square millimeter (MV/mm²) and graded using the Miyata Glistening Density Grading Scale (grades 0-3), where the minimum glistening level corresponds to grade 0 (<25 MV/mm²) and the maximum to grade 3 (101-200 MV/mm²).0 corresponds to <25 MV/mm² and grade 3 to 101-200 MV/mm². Lower Miyata grades indicate a better outcome (=fewer glistenings).

   Measured: single study visit conducted 24 months after IOL implantation of the study eye

4. Monocular Corrected Distance Visual Acuity (CDVA)

   Monocular Corrected Distance Visual Acuity (CDVA) was assessed for each study eye using a standardized visual acuity chart under photopic conditions with the subject's best refractive correction in place. CDVA was recorded in logarithm of the Minimum Angle of Resolution (logMAR), with typical values ranging from about -0.3 (approximately 20/10 Snellen acuity) to 1.0 (approximately 20/200 Snellen acuity), where lower logMAR scores indicate better vision.

   Measured: single study visit conducted 24 months after IOL implantation of the study eye

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted22 Dec 2025
2. Study start25 Dec 2025
3. Primary completion31 Dec 2025
4. Study completion31 Dec 2025

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Other trials for Cataract SenileStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.