DiabetesNCT07076420
Healing of Corneal Incision After Cataract Surgery in Diabetic Patients
An observational study of Diabetes and Cataract, run by Zhongnan Hospital at 1 site in China.
Trial 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?… Read more about this study
- Who is it for?
- Any age
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 15 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Corneal Incision Healing and Its Influencing Factors After Cataract Phacoemulsification in Diabetic Patients -- Based on Anterior Segment Optical Coherence Tomography
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.
- Medical subject headings
- Diabetes Mellitus, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes group | Not described | |
| Control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
volume of half cornea with surgical incision
Measured: 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
Measured: 1 week after surgery; 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Apr 2024
- Primary completion31 Dec 2024
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies 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.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076420
- Sponsor's protocol ID
- 20250122
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen Y, Fu Y, Li L, Li W, Zhang Y, Liu Y, Zhang Q, Ke M. OCT-Based Quantitative Comparison of Full-Thickness Healing of Corneal Incisions in Cataract Surgery Between Diabetic and Nondiabetic Patients. Cornea. 2026 Jun 19. doi: 10.1097/ICO.0000000000004216. Online ahead of print.
PubMed 42312563
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Incision Healing and Its Influencing Factors After Cataract Phacoemulsification in Diabetic Patients -- Based on Anterior Segment Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT07076420
- Acronym / sponsor ID
- 20250122
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes group | – | – |
| Control group | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
volume of half cornea with surgical incision
Time frame: Before surgery; 1 week after surgery; 1 month after surgery
Defect of corneal incision healing
Time frame: 1 week after surgery; 1 month after surgery
Opening of internal orifice; Endothelial dislocation; Descemet's membrane detachment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Derived from this study: PubMed 42312563Chen Y, Fu Y, Li L, Li W, Zhang Y, Liu Y, Zhang Q, Ke M. OCT-Based Quantitative Comparison of Full-Thickness Healing of Corneal Incisions in Cataract Surgery Between Diabetic and Nondiabetic Patients. Cornea. 2026 Jun 19. doi: 10.1097/ICO.0000000000004216. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Cataract, run by Zhongnan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
volume of half cornea with surgical incision (time frame: Before surgery; 1 week after surgery; 1 month after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07076420, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.