Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT02834559
Eligibility Criteria:
Inclusion Criteria:
1. Primary rhegmatogenous retinal detachment (\< 4 weeks) in study eye
2. Scheduled for pars plana vitrectomy for retinal detachment repair without combined cataract surgery in study eye
3. Elevated protein levels in anterior chamber fluid (laser-flare value ≥ 15.0 pc/ms) in study eye
4. Female or male patient ≥ 18 years of age
5. Written informed consent
Exclusion Criteria:
1. Retinal detachment lasting \> 4 weeks in study eye
2. Traumatic retinal detachment in study eye
3. Giant retinal tears in study eye (size \> 3 clock hours)
4. Visual pre-existing PVR grade C in study eye
5. Retinal dystrophies in study eye
6. Scheduled for combined pars plana vitrectomy and cataract surgery for retinal detachment repair in study eye
7. Chronic inflammatory conditions in study eye
8. Active retinal vascular disease in study eye
9. Proliferative diabetic retinopathy in study eye
10. Manifest uveitis in study eye
11. Endophthalmitis in study eye
12. Perforating and non-perforating trauma in study eye
13. Malignant intraocular tumor in study eye
14. Aphakia in study eye
15. Uncontrolled glaucoma or ocular hypertension in study eye (intraocular pressure ≥ 30 mmHg despite IOP lowering therapy)
16. Previous intraocular surgery except uncomplicated cataract surgery with posterior chamber lens implantation in study eye
17. Cataract surgery in study eye ≤ 3 months ago
18. Previous retinal procedures (laserpexy, cryopexy, intravitreal gas-injection, anti-VEGF or corticosteroid-injection) in study eye ≤ 6 months
19. Other uncontrolled ophthalmologic disorders
20. Single eyed patients (BCVA of fellow eye \> 1.0 log MAR, \< 0.1 decimal, \< 1/10 tenth, or \< 6/60 Snellen fraction \[m\])
21. Evidence or history of alcohol, medication or drug dependency within the last 12 months.
22. Evidence or history (within the last 12 months) of neurotic personality, psychiatric illness that requires or required treatment, epilepsy or suicide risk.
23. Systemic disorders not compatible with adjuvant application of 5-FU and LMWH via intraocular infusion, or not compatible with the local or general anesthesia
24. Any therapy with immunosuppressant or chemotherapy ≤ 3 months and during the trial period
25. Participation in another trial of IMPs or devices parallel to, or less than 3 months before screening, or previous participation in this trial.
26. Known to or suspected of not being able to comply with the protocol.
27. Inability to understand the rationale of this trial or the study aim
28. Any dependency of the patient to the Investigator or the trial site, e.g. employees with direct involvement in the proposed trial or in other trials under the direction of this Investigator or trial site, as well as family members of the employees or the Investigator.
29. Positive urine pregnancy test, pregnancy or breastfeeding mother.
30. Women of child bearing potential without satisfactory contraception, i.e. hormonal contraceptives for at least 14 days before trial enrolment, IUD, double barrier (women of child bearing age must be counselled about the use of adequate contraception).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02834559
Study Brief:
Protocol Section:
NCT02834559