Belépés

NCT07355491Befejeződött

Performance Evaluation of Dream OCT: AP Study

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 29.

Rövid összefoglaló (regiszter, angolul)

This study will evaluate the clinical performance of a new swept-source OCT imaging device, the VG200D, and to evaluate substantial equivalence with a predicate device, the Cirrus 5000. Clinical performance will be assessed through an agreement and precision analysis of OCT measurement parameters.

Állapot (regiszter)
Befejeződött
Vizsgálattípus
Megfigyeléses
Résztvevők száma
120 (tényleges)
Első benyújtás
2026. jan. 12.
Kezdés
2025. dec. 16.
Elsődleges befejezés
2026. máj. 12.
Fő szponzor
Intalight, Inc
NCT-szám
NCT07355491

Mit vállalsz

  • Vizsgálat típusa: Megfigyeléses
  • Bevont résztvevők: 120
  • 2025. dec. 16. és az elsődleges befejezés (2026. máj. 12.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Más betegség

  • Subject has a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
  • Subject has a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
  • Subject has a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
  • Subject has a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study

Egyéb

  • Subjects unable to tolerate ophthalmic imaging
  • Subjects not able to obtain acceptable OCT images due to ocular media opacity or other reasons
  • Presence of any ocular pathology except for cataract in either eye
  • Subjects unable to tolerate ophthalmic imaging
  • Subjects not able to obtain acceptable OCT images due to ocular media opacity or other reasons
  • No reliable Humphrey Field Analyzer (HFA) visual field (24-2 SITA Standard or Fast, 10-2, white on white) result within the past year of the study visit, defined as fixation losses \> 33%, or false positives \> 33%, or false negatives \> 33% in the study eye
  • Subjects unable to tolerate ophthalmic imaging
  • Subjects not able to obtain acceptable OCT images due to ocular media opacity or other reasons
  • Subjects unable to tolerate ophthalmic imaging
  • Subjects not able to obtain acceptable OCT images due to ocular media opacity or other reasons

Kiket keres a vizsgálat

  • Subjects 22 years of age or older on the date of informed consent
  • Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
  • Subjects with normal eye examinations in both eyes on the date of the study visit as observed with a 90 diopter lens
  • BCVA 20/40 or better (each eye) on the date of the study visit
  • Subjects 22 years of age or older on the date of informed consent
  • Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
  • BCVA 20/40 or better in the study eye
  • History of Visual field defects within the previous year from the study visit or measured the day of the study visit consistent with glaucomatous optic nerve damage with at least one of the following two findings:
    • On pattern deviation (PD), there exists a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level;
    • Glaucoma hemi-field test "outside normal limits."
  • Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities:
    • Diffuse thinning, focal narrowing, or notching of the neuroretinal rim, especially at the inferior or superior poles with or without disc hemorrhage;
    • Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue
  • Subjects 22 years of age or older on the date of informed consent
  • Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
  • BCVA 20/400 or better in the study eye
  • Diagnosis of some type of retinal pathology by investigator, may include, but not limited to: Macular Degeneration (including patients with drusen and geographic atrophy and choroidal neovascularization), Diabetic Macular Edema, Diabetic Retinopathy, Macular Hole, Epiretinal Membrane, Central Serous Retinopathy, Vein or artery Occlusions and others
  • Subjects 22 years of age or older on the date of informed consent
  • Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
  • Subjects with one of the following corneal abnormalities:
    • Cornea disease (e.g., Fuch's or other) ii. Keratoconus iii. Cornea transplant iv. Post refractive surgery (e.g., LASIK or other) v. Dry Eye Syndrome vi. Long-term contact wearers (greater than 1 year)
  • BCVA 20/400 or better in the study eye

Életkor a regiszterben: 22 év – - · Nem: nők és férfiak · Egészséges önkénteseket is fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Illinois College of Optometry
Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát
ChicagoEgyesült ÁllamokIsmeretlen állapot

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