Retinitis Pigmentosa Klinik Ölçümleri ve Olası Sonuç Ölçütlerinin Tekrarlanabilirlik Testi

Sade dilde özet

Bu araştırma, retinitis pigmentosa adı verilen kalıtsal göz hastalığında kullanılabilecek klinik ölçüm yöntemlerinin ve olası sonuç ölçütlerinin güvenilirliğini (tekrarlanabilirliğini) değerlendirmektedir. Çalışmaya, karakteristik bulgularla retinitis pigmentosa tanısı olan 12 yaş ve üzeri kişiler ile sağlıklı gönüllüler katılabilmiştir. Çalışma faz uygulanmayan bir çalışma olarak yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

N/A

Durum

Tamamlandı

Sponsor

National Eye Institute (NEI)

Başlangıç

27.09.2019

Tahmini bitiş

19.07.2023

Ülkeler

United States

İlgili genler

Merkezler

• Bethesda, United States

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

* INCLUSION CRITERIA for RP Participants:

To be eligible, the following inclusion criteria must be met, where applicable.

* Participant must be 12 years of age or older.
* Participant (or legal guardian) must understand and sign the protocol s informed consent document.
* Participant must have evidence of RP as defined by characteristic ERG responses, visual fields, clinical exam and /or genetic testing.

INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:

To be eligible, the following inclusion criteria must be met:

1. Participant must be 18 years of age or older.
2. Participant must understand and sign the protocol s informed consent document.
3. Participant must not have evidence of RP.

EXCLUSION CRITERIA FOR ALL PARTICIPANTS:

A participant is not eligible if any of the following exclusion criteria are present.

* Participant is actively receiving study therapy in another investigational study.
* Participant is started on (or changed dosage of) topical or systemic carbonic anhydrase inhibitor (CAI) treatment in the three months prior to enrollment.
* Participant is expected to be unable to comply with study procedures or follow-up visits.
* Participant has evidence of an ocular disease other than RP in either eye that may confound the outcome of the study (e.g., diabetic retinopathy with ten or more hemorrhages or microaneurysms, uveitis, pseudovitelliform macular degeneration, severe myopia).
* Participant is taking ocular or systemic medications known to be toxic to the lens, retina or optic nerve (e.g., ethambutol, chloroquine, or hydroxychloroquine).
* Participant has a condition that would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control) by interfering with the participant s ability to engage in the required protocol evaluation and testing and/or comply with study visits.
* Participant is an NIH employee associated with this study.
* Participant is unable or unwilling to give informed consent that includes use of medical records and clinical samples for current and future research.