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Evaluation and Treatment of Patients With Retinal Disease

30. juni 2017 opdateret af: National Eye Institute (NEI)

Evaluation and Treatment Protocol for Patients With Retinal Disease

This study offers evaluation and treatment for patients with certain diseases of the retina (the layer of light-sensitive tissue that lines the inside of the eyeball). The protocol is not designed to test new treatments; rather, patients will receive the current standard of care for his or her specific condition. The purpose of the study is twofold: 1) to allow National Eye Institute physicians to increase their knowledge of retinal eye diseases and identify possible new avenues of research in this area; and 2) to establish a pool of patients who may be eligible for new studies as they are developed. (Participants in this protocol will not be required to join a new study; the decision will be voluntary.)

Patients with diabetic retinopathy, age-related macular degeneration, vascular occlusive disease, central serous retinopathy or another retinal disease may be eligible for this study. Candidates will be screened with a medical history, brief physical examination, thorough eye examination and blood test. The eye examination includes measurements of eye pressure and visual acuity (ability to see the vision chart), examination of the pupils and eye movements, and dilation of the pupils to examine the lens and retina. Patients will also undergo fundus photography and fluorescein angiography, as follows:

  • Fundus photography - Special photographs of the inside of the eye to help evaluate the status of the retina and evaluate changes that may occur in the future. From 2 to 20 pictures may be taken, depending on the eye condition. The camera flashes a bright light into the eye for each picture.
  • Fluorescein angiography - Procedure to evaluate the eye's blood vessels. A yellow dye injected into an arm vein travels to the blood vessels in the eyes. Pictures of the retina are taken using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible blood vessel abnormality.

Participants will be followed at least 3 years. Follow-up visits are scheduled according to the standard of care for the individual patient's eye problem. It is estimated that most patients will have from one to four follow-up visits each year. Vision will be checked at each visit, and some of the screening tests described above may be repeated to follow the progress of disease and evaluate the response to treatment.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

This 'Evaluation and Treatment Protocol' will allow the retinal specialists at the NEI to identify, follow and provide "standard of care" treatment to patients with various retinal diseases. A primary purpose of the protocol is to accumulate a cohort of patients with retinal diseases for possible participation in new clinical trials and epidemiological protocols. Also, by providing long-term follow-up and treatment for a variety of retinal diseases, the retinal specialists at NEI will be better able to identify research hypotheses about these diseases in addition to maintaining their clinical skills. The availability of cohorts of patients with a spectrum of retinal diseases will be valuable for the training of retinal fellows, an important mission of the NEI. The ability to provide long-term follow-up and care will also facilitate referral efforts for new NEI protocols.

The retinal specialists at the National Eye Institute will be free to choose those retinal diseases that interest them. However, the total number of patients that can be enrolled in the protocol will be restricted. This protocol is not designed to test any new treatments. Any evaluations or treatment under this protocol will be based on the current standard of care for each retinal disease.

Participants in this patient evaluation and treatment protocol will be evaluated for potential eligibility in any new NEI clinical trials or epidemiologic protocols as they are developed. If eligible, patients may be asked to participate in the new protocol. However, they will not be required to enter any protocol and their decision to participate will be entirely voluntary. No more than 150 patients will be accepted in this "Evaluation and Treatment Protocol."

Undersøgelsestype

Observationel

Tilmelding

1000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Maryland
      • Bethesda, Maryland, Forenede Stater, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

10 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

  • INCLUSION CRITERIA:

Each study participant must have the ability to understand and sign an informed consent form.

Patients with diabetic retinopathy and age-related macular degeneration.

Patients with vascular occlusive disease, central serous retinopathy, or rare/unknown retinal disease.

EXCLUSION CRITERIA:

Patients will be excluded from this study if they are unable or unwilling to give informed consent or they are unwilling to be followed and treated at the NEI Clinical Center for at least the next 3 years.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

31. maj 2000

Studieafslutning

8. august 2008

Datoer for studieregistrering

Først indsendt

3. juni 2000

Først indsendt, der opfyldte QC-kriterier

3. juni 2000

Først opslået (Skøn)

5. juni 2000

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juli 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juni 2017

Sidst verificeret

8. august 2008

Mere information

Begreber relateret til denne undersøgelse

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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