Clinical trial NCT06638424: Study of the Impact of Cataract Surgery on the Corneal Epithelium and Ocular Surface of Diabetic Patients
Official title: Study of the Impact of Cataract Surgery on the Corneal Epithelium and Ocular Surface of Diabetic Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cataract Diabetic
Keywords: Cataract
Diabetes
Corneal epithelium
Lacrimal gland
Corneal neuropathy
Meibomian dysfunction
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient (≥18 years) operated on for cataract at HUS between January 2022 and January 2024;

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To assess whether cataract surgery induces an increased risk of corneal epithelial alterations in diabetic patients
timeFrame: One month before and one month after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Ophtalmologie - CHU de Strasbourg - France
Study officials:
References: