Prospective, single-center, interventional follow-up study to determine the effect of prostate carcinoma and its operative therapy on intraocular pressure and determination of potential mediators.

Phase 4

• Conditions: prostate cancer, mamma carcinoma, colorectal carcinoma; H40.1; Primary open-angle glaucoma

• Registration Number: DRKS00015830
• Lead Sponsor: Diakonie Klinikum Dietrich Bonhoeffer GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-11
• Study Completion: 2022-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

For the test group with prostate cancer
1. Patients with prostate cancer (all stages) on whom a radical prostatectomy is planned in Neubrandenburg
2. Willingness of patients to participate in the study with an informed written consent

For the comparison group
1. Patient of the eye clinic, male sex
2. no history of prostate cancer known
3. PSA value =4.5 ng / ml
4.Willingness of patients to participate in the study with written consent

For the test group with breast cancer
1. Patients with breast cancer (all stages)
2. Willingness of patients to participate in the study with written consent

For the test group with colorectal cancer
1. Patients with colorectal cancer (all stages)
2. Willingness of patients to participate in the study with written consent

Exclusion Criteria

For all test groups
1. Glaucoma (anamnesis and HRT examination)
2. Other eye disease that interferes with an IOP measurement or examination of the anterior segment of the eye
3. Malignant disease other than prostate cancer, breast cancer and colon cancer (currently or within the last 15 years)
4. Rheumatologic or autoimmune disease
5. Allergy to eye drops with local anesthetics, fluorescein and preservatives

For the comparison group
1. Glaucoma (anamnesis and HRT examination)
2. Other eye disease that interferes with IOP measurement or examination of the anterior segment of the eye
3. Malignant disease (current or within the last 15 years)
4. Rheumatologic or autoimmune disease
5. history of prostate cancer
6. increased PSA value
7. Allergy to eye drops with local anesthetics, fluorescein and preservatives

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Does the intraocular pressure differ between patients with prostate cancer and a healthy comparison group? Does the intraocular pressure in prostate cancer, breast cancer or colorectal cancer patients change after surgical tumor removal compared to preoperative values? Is there a difference in systemic levels of potential chemical mediator between prostate cancer patients and a healthy comparison group? Do the absolute values and their postoperative change correlate with the intraocular pressure?<br>After completing the recruitment, the data of all four patient groups are evaluated with the program STATISTICA (StatSoft).

Secondary Outcome Measures

Name	Time	Method
Does the intraocular pressure or the postoperative pressure change correlate with pre-, intra- or postoperative data of patients with prostate cancer, breast cancer or colorectal cancer (including histological findings and tumor staging)?<br>After completing the recruitment, the data of all four patient groups are evaluated with the program STATISTICA (StatSoft).