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

Recruiting

• Conditions: Cataract Diabetic

• Registration Number: NCT06638424
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-22
• Status Verified: 2024-10
• Study First Submitted: 2024-10-09
• Study First Submitted QC: 2024-10-09
• Last Update Submitted: 2024-10-09
• Study First Posted: 2024-10-11
• Last Update Posted: 2024-10-11
• Primary Completion: 2025-04
• Study Completion: 2025-04-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess whether cataract surgery induces an increased risk of corneal epithelial alterations in diabetic patients	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

Trial Locations

Locations (1)

Service d'Ophtalmologie - CHU de Strasbourg - France; 🇫🇷 Strasbourg, France