Telescope Exchange Study
Schlüsselwörter
Abstrakt
Termine
| Zuletzt überprüft: | 03/31/2018 |
| Zuerst eingereicht: | 01/01/2017 |
| Geschätzte Einschreibung eingereicht: | 01/03/2017 |
| Zuerst veröffentlicht: | 01/04/2017 |
| Letztes eingereichtes Update: | 04/24/2018 |
| Letztes Update veröffentlicht: | 04/25/2018 |
| Tatsächliches Startdatum der Studie: | 03/21/2017 |
| Geschätztes primäres Abschlussdatum: | 11/30/2019 |
| Voraussichtliches Abschlussdatum der Studie: | 12/30/2022 |
Zustand oder Krankheit
Intervention / Behandlung
Device: Implantable Miniature Telescope (IMT)
Phase
Armgruppen
| Arm | Intervention / Behandlung |
|---|---|
| Experimental: Implantable Miniature Telescope (IMT) Intervention: Implanting the Implantable Miniature Telescope (IMT) in pseudophakic eyes of patients suffering from binocular end-stage AMD. | Device: Implantable Miniature Telescope (IMT) Monocular implantation of the IMT. |
Zulassungskriterien
| Altersberechtigt für das Studium | 65 Years Zu 65 Years |
| Studienberechtigte Geschlechter | All |
| Akzeptiert gesunde Freiwillige | Ja |
| Kriterien | Inclusion Criteria: - Have retinal findings of geographic atrophy or disciform scar with foveal involvement as determined by FA - Be age 65 or older - Have BCDVA between 20/160 to 20/800 (inclusive) on ETDRS chart - Be pseudophakic in the eye selected for telescope implantation - Agree to undergo pre-surgery training with a low vision specialist - Achieve at least a 5-letter improvement on the ETDRS chart with an external telescope - Agree to participate in postoperative vision training with a low vision specialist. - Patients must be able to provide and sign a voluntary informed consent. - Patients must not meet any of the exclusion criteria below. Exclusion Criteria: - Stargardt's macular dystrophy - Cognitive impairment that would interfere with the ability to understand instructions, follow directions, or prevent proper visual training/rehabilitation with the device. - Any ophthalmic pathology that compromises fellow-eye peripheral vision - A history of steroid-responsive rise in intraocular pressure (IOP), uncontrolled glaucoma, or preoperative IOP >22mmHg while on maximum medication - Known sensitivity to planned study concomitant medications. - An ocular condition that predisposes the patient to eye rubbing. - Patients participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation. - Operative eye with: - Evidence of active CNV or treatment of CNV within 6 months - IOLs of the following types: PMMA, Crystalens, Tetraflex, Synchrony. - Central anterior chamber depth (ACD) < 3.0 mm; measurement of the ACD should be taken from the posterior surface of the cornea (endothelium) to the anterior surface of the IOL. - Axial length < 21 mm or >27 mm - Endothelial cell density (ECD) lower than 2300 cells/mm2 for subjects between the ages 65-69, lower than 2000 cells/mm2 for subjects between the ages of 70-74, and lower than 1800 cells/mm2 for subjects 75 years old or greater. - Corneal stromal or endothelial dystrophies, including guttata - History of intraocular or corneal surgery (including DSEK) except cataract removal and IOL placement - History of complicated cataract surgery - Compromised capsular bag (previous YAG posterior capsulotomy, evidence of tearing) - History of Radial Keratotomy - Inflammatory ocular disease - Pseudoexfoliation or zonular weakness - Diabetic retinopathy - Untreated retinal tears - Retinal vascular disease - Optic nerve disease - A history of retinal detachment - Intraocular tumor - Retinitis pigmentosa - Prior or expected ophthalmic related surgery within 30 days preceding telescope implantation - Any medical or ophthalmic condition that in the opinion of the investigator renders the subject unsuitable for participation in the study |
Ergebnis
Primäre Ergebnismaße
1. Adverse events [Subjects will be followed up for three years post implantation]
Sekundäre Ergebnismaße
1. Decrease in best corrected distance visual acuity (BCDVA) [Subjects will be followed up for three years post implantation]
2. Endothelial Cell Density [Subjects will be followed up for three years post implantation]
Sonstige Ergebnismaßnahmen
1. Increase in best corrected distance visual acuity (BCDVA) [Subjects will be followed up for three years post implantation]
