NCT07076420

Brief Summary

The objective of this observational study was to understand the healing of corneal incision after cataract surgery in diabetic patients and its influencing factors. The main questions it aims to answer are: Is corneal incision healing worse in diabetic patients after cataract surgery than in non-diabetic patients? What are the factors affecting corneal incision healing after cataract surgery in diabetic patients? The results of anterior segment optical coherence tomography before and after cataract surgery in cataract patients with or without diabetes will be collected and analyzed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

9 months

First QC Date

July 14, 2025

Last Update Submit

July 14, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • volume of half cornea with surgical incision

    Before surgery; 1 week after surgery; 1 month after surgery

  • Defect of corneal incision healing

    Opening of internal orifice; Endothelial dislocation; Descemet's membrane detachment

    1 week after surgery; 1 month after surgery

Study Arms (2)

Diabetes group

Control group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who were initially diagnosed with cataract and treated with phacoemulsification and intraocular lens implantation at Zhongnan Hospital of Wuhan University from April 1, 2024 to December 31, 2024.

You may qualify if:

  • Patients who experience blurred vision and painless visual acuity decline, and are diagnosed with cataract (with or without diabetes) through reliable intraocular pressure, visual acuity and slit lamp examinations, and for whom phacoemulsification of cataract can be considered.

You may not qualify if:

  • Use multiple eye drops before surgery.
  • Complicated by other eye diseases that affect corneal healing, such as keratitis, uveitis, glaucoma, etc.
  • Moderate to severe dry eye.
  • History of eye surgery.
  • Moderate to severe dry eye.
  • Grade 5 nuclear cataract.
  • Severe systemic diseases (such as chronic renal failure requiring dialysis, severe neurological diseases, immune diseases), pregnancy or lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location

MeSH Terms

Conditions

Diabetes MellitusCataract

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLens DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2025

First Posted

July 22, 2025

Study Start

April 1, 2024

Primary Completion

December 31, 2024

Study Completion

January 15, 2025

Last Updated

July 22, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations