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NCT Number: NCT06638424

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service d'Ophtalmologie - CHU de Strasbourg - France

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Emilia KOESTEL, MD

SUB_INVESTIGATOR

Tristan BOURCIER, MD, PhD

CONTACT

[email protected]

33 3 69 55 11 16

Tristan BOURCIER, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Tristan BOURCIER, MD, PhD

CONTACT

[email protected]

33 3 69 55 11 16

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: CATARA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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