Time Efficiency Comparison of Two IntraVitreal Injection Techniques
Açar sözlər
Mücərrəd
Təsvir
Prospective, single-center, randomized, clinical trial (RCT) comparing the efficiency and safety of a single-use IIG with a traditional technique using a dual blade speculum among patients undergoing IVI for various indications.
The investigators will include eyes of adult patients scheduled to undergo unilateral or bilateral IVI for neovascular age-related macular degeneration (nAMD), polypoidal choroidal vasculopathy (PCV), diabetic macular edema (DME), retinal vein occlusion (RVO), choroidal neovascular membrane from pathologic myopia (PM) and uveitis. The investigators will exclude eyes with a history of extraocular or intraocular infection within 3 months of the scheduled IVI date, scleral thinning, history of previous glaucoma surgery, history of pars plana vitrectomy, hypersensitity to the IVI drug, propracaine or povidone iodine, and inability to understand the informed consent form.
The eyes will be randomly assigned in 1:1 fashion into two injection arms: intravitreal injection guide (IIG) and dual blade speculum (DBS). At the time of injection, a random number generator will be used to generate an odd or even number for each eye. Odd eyes will be assigned to IIG and even eyes will be assigned to DBS. For same day bilateral injection, once the first eye is randomized to one technique, the second eye will be automatically assigned to the other technique. The study will be conducted in compliance with the Declaration of Helsinki. All patients will provide informed consent prior to start of study procedures.
Tarixlər
| Son Doğrulandı: | 06/30/2020 |
| İlk təqdim: | 06/27/2020 |
| Təxmini qeydiyyat təqdim edildi: | 06/30/2020 |
| İlk Göndərmə: | 07/01/2020 |
| Son Yeniləmə Göndərildi: | 07/02/2020 |
| Son Yeniləmə Göndərildi: | 07/06/2020 |
| Həqiqi Təhsilin Başlama Tarixi: | 06/30/2020 |
| Təxmini İlkin Tamamlanma Tarixi: | 09/30/2020 |
| Təxmini İşin Tamamlanma Tarixi: | 09/30/2020 |
Vəziyyət və ya xəstəlik
Müdaxilə / müalicə
Device: Intravitreal injection guide
Device: Dual blade eyelid speculum
Faza
Qol Qrupları
| Qol | Müdaxilə / müalicə |
|---|---|
| Other: Intravitreal injection guide Single use, combination ocular surface caliper to determine point of intravitreal injection and set-depth injection guide to limit injection needle entry into the eye | Device: Intravitreal injection guide A single use, multifunction device will be used to push away an eyelid to expose injection site, indicate injection point about 4 millimeters from surgical limbus, and directs needle perpendicular to the ocular surface while limiting intraocular needle incursion |
| Other: Dual blade eyelid speculum Dual blade eyelid speculum to open eyelids followed by Castroviejo surgical caliper to measure injection point 3.5 mm from limbus | Device: Dual blade eyelid speculum A conventional dual blade eyelid speculum will be use to push away eyelids. A Castroviejo surgical caliper will be used to mark the injection site. |
Uyğunluq Kriteriyaları
| Təhsil üçün uyğun yaşlar | 21 Years Üçün 21 Years |
| Təhsilə Uyğun Cinslər | All |
| Sağlam Könüllüləri qəbul edir | Bəli |
| Kriteriyalar | Inclusion Criteria: * Eyes of adult patients requiring intravitreally injected medications for non-infectious indications Exclusion Criteria: - History of extraocular or intraocular infection within 3 months of the scheduled IVI date - Scleral thinning - History of previous glaucoma surgery - History of pars plana vitrectomy - Hypersensitivity to the IVI drug, proparacaine or povidone iodine - Inability to understand the informed consent form |
Nəticə
İlkin nəticə tədbirləri
1. Duration of intravitreal injection procedure [At time of injection procedure]
İkincili Nəticə Tədbirləri
1. Adverse event rate [Immediately and up to 1 month after the intravitreal injection procedure]
