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

NCT06638424 | Recruiting

• 1 other identifier: 9246
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract Diabetic

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  One month before and one month after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patient (≥18 years) operated on for cataract at HUS between January 2022 and January 2024;

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service d'Ophtalmologie - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 40597813 DERIVED

MeSH Terms

Conditions

Cataract; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Tristan BOURCIER, MD, PhD

CONTACT

33 3 69 55 11 16; tristan.bourcier@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: April 22, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 22, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

FR (1)