Surgical outcomes of corneal refractive surgery in patients with stable systemic disease.

• Conditions: H52.7; K52; Disorder of refraction, unspecified; Type 2 diabetes mellitus; E11; L20; M06; Other noninfective gastroenteritis and colitis; L40; F32

• Registration Number: DRKS00030317
• Lead Sponsor: Heinrich-Heine-Universität Düsseldorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-08-30
• Study Start: 2023-04-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 5807

Inclusion Criteria

age > 18 years
refractive stability longer than 1 year
high ametropia (> 1,5D)
desire to be free of glasses
presence of a systemic disease such as:
- Diabetes mellitus
- rheumatic diseases (e.g. rheumatoid arthritis)
- neurodermatitis
- psoriasis
- Chronic inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis)
- Hay fever
- Taking antidepressants
- Bechterew's disease (Ankylosing Spondylitis)

Exclusion Criteria

visus-limiting eye diseases
Keratoconus
Pregnancy
Lactation

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate safety, the safety index (SI) is calculated. This is defined as the ratio of postoperative corrected distance visual acuity (CDVA) to preoperative corrected distance visual acuity (CDVA). <br>To assess efficacy, the efficacy index (EI) is calculated. This is defined as the ratio of postoperative uncorrected distance visual acuity (UDVA) to preoperative corrected distance visual acuity (CDVA).<br>Good predictability is achieved if the postoperative correction achieved is within ± 0.5 dpt around the preoperatively targeted spherical equivalent (SE).

Secondary Outcome Measures

Name	Time	Method
Visual results using Snellen vision chart