NCT07672899

Brief Summary

The goal of this observational study is to evaluate the expression characteristics and clinical relevance of the tRF-31/HIPK2 signaling axis in adults over 18 years old with age-related cataract (ARC). The main questions it aims to answer are: Is there a correlation between the relative expression levels of tRF-31 and its target gene HIPK2 in the anterior lens capsule and the clinical severity (Emery-Little grading system) of age-related cataracts? Does oxidative stress in the anterior segment microenvironment have a potential bystander effect on the state of the corneal endothelium? Participants will:Undergo routine preoperative ophthalmologic examinations, including visual acuity tests, slit-lamp photography, and corneal endothelial cell counting. Undergo standard cataract surgery (phacoemulsification combined with intraocular lens implantation) as part of their regular medical care. Allow researchers to collect and analyze their anterior lens capsule tissue, which is routinely removed and typically discarded as medical waste during the standard continuous curvilinear capsulorhexis (CCC) step of the surgery.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Jun 2026Sep 2026

Study Start

First participant enrolled

June 17, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2026

Last Updated

June 29, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

June 23, 2026

Last Update Submit

June 23, 2026

Conditions

Keywords

age-related cataractoxidative stresstRNA-derived small RNA

Outcome Measures

Primary Outcomes (1)

  • Correlation between relative expression of tRF-31 and cataract nuclear hardness (Emery-Little grading system)

    Baseline (Preoperative, up to 1 month prior to surgery)

Interventions

This is an observational study without investigational interventions. Participants will undergo standard-of-care phacoemulsification combined with intraocular lens implantation for age-related cataract. During the routine continuous curvilinear capsulorhexis (CCC) step of the surgery, the central anterior lens capsule, which is typically discarded as medical waste, will be collected for subsequent molecular analysis. This tissue collection relies entirely on the standard surgical procedure and does not alter the patient's routine clinical treatment pathway in any way.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of adult patients over 18 years of age who have been clinically diagnosed with age-related cataract (ARC) and are scheduled to undergo routine phacoemulsification combined with intraocular lens implantation at the Eye Center of the Second Affiliated Hospital, Zhejiang University School of Medicine.

You may qualify if:

  • Patients older than 18 years. Clinically diagnosed with age-related cataract (ARC) and have clear surgical indications for routine phacoemulsification combined with intraocular lens (IOL) implantation. Scheduled to undergo cataract extraction and intraocular lens implantation. Completed routine preoperative corneal endothelial specular microscopy, providing objective data including cell density, coefficient of variation of cell area, and the proportion of hexagonal cells. Provided signed written informed consent.

You may not qualify if:

  • History of ocular trauma, glaucoma, episodes of active uveitis, or previous intraocular surgery. Presence of severe systemic diseases rendering the patient unsuitable for surgery. Poor patient compliance or coexisting psychiatric disorders. Severe systemic metabolic syndromes (e.g., diabetes). Diagnosis of high myopia. Current participation in other clinical trials or likelihood of being lost to follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2026

First Posted

June 29, 2026

Study Start

June 17, 2026

Primary Completion (Estimated)

August 16, 2026

Study Completion (Estimated)

September 16, 2026

Last Updated

June 29, 2026

Record last verified: 2026-06

Locations