Cataract DiabeticCATARANCT06638424
Study of the Impact of Cataract Surgery on the Corneal Epithelium and Ocular Surface of Diabetic Patients
An observational study of Cataract Diabetic, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Diabetes is one of the most common fatal metabolic diseases in the world. Diabetes-induced ocular surface alterations are poorly understood. Indeed, it was once thought that the cornea, avascular, was immune to the effects of diabetes. A growing number of publications now demonstrate the opposite. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract Diabetic
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 22 Apr 2024to 22 Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient (≥18 years) operated on for cataract at HUS between January 2022 and January 2024;
Who may be able to join
- Adult patient (≥18 years);
- Patient operated on for cataract at HUS between January 2022 and January 2024;
- Patient who did not express his opposition to the reuse of his data for scientific research purposes;
- Patient who benefited from the measurement of the above-mentioned judgment criteria during his pre- and post-operative consultations.
Who cannot join
- Presence in the medical file of the subject's opposition to the reuse of his data for scientific research purposes.
- Prolonged use of stored eye drops;
- Documented etiology of chronic alteration of the ocular surface (shingles, herpes, Gougerot-Sjogren syndrome, graft-versus-host disease);
- Minor patient or under guardianship or curatorship.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'Ophtalmologie - CHU de Strasbourg - France
Strasbourg, 67091
Tristan BOURCIER, MD, PhD, 33 3 69 55 11 16, tristan.bourcier@chru-strasbourg.fr
Tristan BOURCIER, MD, PhD
About this study
Diabetes is one of the most common fatal metabolic diseases in the world. Diabetes-induced ocular surface alterations are poorly understood. Indeed, it was once thought that the cornea, avascular, was immune to the effects of diabetes. A growing number of publications now demonstrate the opposite. These alterations affect up to 70% of diabetic patients at some point in the progression of their diabetes.
Another common complication of diabetes is the early development of a cataract, requiring surgery. Diabetic patients are therefore more likely to require surgery at an early age than the general population.
Read more
Diabetes and cataract surgery both induce corneal changes. Cataract surgery in diabetic patients is therefore at greater risk of corneal complications. Diabetes induces dysfunction of the main lacrimal gland, corneal neuropathy, meibomian dysfunction and a decrease in conjunctival mucus cells. Diabetic patients are therefore particularly at risk of exacerbation or appearance of alterations of the corneal epithelium and the ocular surface in postoperative cataract surgery.
Therefore, it seems necessary to evaluate the impact of cataract surgery on the ocular surface and corneal epithelium of diabetic patients, in order to improve their management.
- Conditions
- Cataract Diabetic
- Keywords
- Cataract, Diabetes, Corneal epithelium, Lacrimal gland, Corneal neuropathy, Meibomian dysfunction
- Medical subject headings
- Cataract, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess whether cataract surgery induces an increased risk of corneal epithelial alterations in diabetic patients
The six Oxford scheme grades (0-5), which denote the severity of dry eye, are used to record the results:
- Stage 0 or 1: Mild
- Stage 2 or 3: Moderate
- Stage 4 or 5: Severe
Measured: One month before and one 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 posted15 Oct 2024
- Study start22 Apr 2024
- Primary completionApr 2025 (estimated)
- Study completion22 Apr 2025 (estimated)
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 Cataract DiabeticStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638424
- Sponsor's protocol ID
- 9246
- Acronym
- CATARA
- Status last verified
- Oct 2024
- First submitted
- 9 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Koestel E, Dormegny L, Sauer A, Gaucher D, Bourcier T. Ocular surface changes and corneal epithelial remodeling after cataract surgery in patients with type 2 diabetes: a case-control study. BMC Ophthalmol. 2025 Jul 1;25(1):355. doi: 10.1186/s12886-025-04178-6.
PubMed 40597813
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of Cataract Surgery on the Corneal Epithelium and Ocular Surface of Diabetic Patients
- ClinicalTrials.gov ID
- NCT06638424
- Acronym / sponsor ID
- CATARA / 9246
- Conditions
- Cataract Diabetic
- Keywords
- Cataract, Diabetes, Corneal epithelium, Lacrimal gland, Corneal neuropathy, Meibomian dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- 22 Apr 2025 (estimated)
- First posted
- 15 Oct 2024 (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.
Diabetes is one of the most common fatal metabolic diseases in the world. Diabetes-induced ocular surface alterations are poorly understood. Indeed, it was once thought that the cornea, avascular, was immune to the effects of diabetes. A growing number of publications now demonstrate the opposite. These alterations affect up to 70% of diabetic patients at some point in the progression of their diabetes.
Another common complication of diabetes is the early development of a cataract, requiring surgery. Diabetic patients are therefore more likely to require surgery at an early age than the general population.
Diabetes and cataract surgery both induce corneal changes. Cataract surgery in diabetic patients is therefore at greater risk of corneal complications. Diabetes induces dysfunction of the main lacrimal gland, corneal neuropathy, meibomian dysfunction and a decrease in conjunctival mucus cells. Diabetic patients are therefore particularly at risk of exacerbation or appearance of alterations of the corneal epithelium and the ocular surface in postoperative cataract surgery.
Therefore, it seems necessary to evaluate the impact of cataract surgery on the ocular surface and corneal epithelium of diabetic patients, in order to improve their management.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient (≥18 years) operated on for cataract at HUS between January 2022 and January 2024;
Key inclusion criteria (4 listed)
- Adult patient (≥18 years);
- Patient operated on for cataract at HUS between January 2022 and January 2024;
- Patient who did not express his opposition to the reuse of his data for scientific research purposes;
- Patient who benefited from the measurement of the above-mentioned judgment criteria during his pre- and post-operative consultations.
Key exclusion criteria (4 listed)
- Presence in the medical file of the subject's opposition to the reuse of his data for scientific research purposes.
- Prolonged use of stored eye drops;
- Documented etiology of chronic alteration of the ocular surface (shingles, herpes, Gougerot-Sjogren syndrome, graft-versus-host disease);
- Minor patient or under guardianship or curatorship.
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
To assess whether cataract surgery induces an increased risk of corneal epithelial alterations in diabetic patients
Time frame: One month before and one month after surgery
The six Oxford scheme grades (0-5), which denote the severity of dry eye, are used to record the results: * Stage 0 or 1: Mild * Stage 2 or 3: Moderate * Stage 4 or 5: Severe
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 40597813Koestel E, Dormegny L, Sauer A, Gaucher D, Bourcier T. Ocular surface changes and corneal epithelial remodeling after cataract surgery in patients with type 2 diabetes: a case-control study. BMC Ophthalmol. 2025 Jul 1;25(1):355. doi: 10.1186/s12886-025-04178-6.
Related trials for Cataract Diabetic
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruitingObservational study
A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
Age- Related Macular Degeneration, Diabetic Retinopathy
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
Not yet recruitingObservational study
Study on Eye-Brain Cross-Organ Mapping and Systemic Disease Association Based on Multimodal Big Data
Cataract, Vitreous Hemorrhage
Active, not recruiting
Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT)
Glaucoma, Vision Impairment and Blindness
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.
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 Cataract Diabetic, run by University Hospital, Strasbourg, France at 1 site in France.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 15 Oct 2024. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tristan BOURCIER, MD, PhD (33 3 69 55 11 16, tristan.bourcier@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess whether cataract surgery induces an increased risk of corneal epithelial alterations in diabetic patients (time frame: One month before and one month after surgery). 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 NCT06638424, 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 15 Oct 2024.