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Study of the Impact of Cataract Surgery on the Corneal Epithelium and Ocular Surface of Diabetic Patients

Study of the Impact of Cataract Surgery on the Corneal Epithelium and Ocular Surface of Diabetic Patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06638424
Acronym
CATARA
Enrollment
150
Registered
2024-10-15
Start date
2024-04-22
Completion date
2025-04-22
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract Diabetic

Keywords

Cataract, Diabetes, Corneal epithelium, Lacrimal gland, Corneal neuropathy, Meibomian dysfunction

Brief 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. 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.

Interventions

None listed

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
To assess whether cataract surgery induces an increased risk of corneal epithelial alterations in diabetic patientsOne month before and one month after surgeryThe 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

Countries

France

Contacts

Primary ContactTristan BOURCIER, MD, PhD
tristan.bourcier@chru-strasbourg.fr33 3 69 55 11 16

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026