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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00030317

Enrollment

5000

Registered

2023-04-06

Start date

2021-05-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

H52.7 E11 K52 L40 F32 J30 L20 M06 M45

Interventions

Group 1: LASIK in patients with diabetes mellitus: To investigate the efficacy, safety, and predictability of refractive outcomes in terms of CDVA and UDVA, respectively, pre- and postoperatively (2 w

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria: visus-limiting eye diseases Keratoconus Pregnancy Lactation

Design outcomes

Primary

Measure	Time frame
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). 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). Good predictability is achieved if the postoperative correction achieved is within ± 0.5 dpt around the preoperatively targeted spherical equivalent (SE).	—

Measure

Time frame

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). 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). Good predictability is achieved if the postoperative correction achieved is within ± 0.5 dpt around the preoperatively targeted spherical equivalent (SE).

—

Secondary

Measure	Time frame
Visual results using Snellen vision chart	—

Countries

Germany

Contacts

Public ContactAndreas Frings

Heinrich-Heine-Universität Düsseldorf

info@augenarzt-frings.de+49 911 235 558 25

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026