Clinical trials: IMPLANTATION
Presbyopia
Trial of the PresVIEW Implant for the Improvement of Near Vision in Patients With Presbyopia
The primary objective of this study is to evaluate the safety and effectiveness of the PresVIEW™ Scleral Implant (PSI) for the improvement of near visual acuity in presbyopic patients.
- Trial name
- NCT01166568
- Testing
- PresVIEW Scleral Implants
- Where
- 14 sites in United States
- Volunteers
- 337 people, healthy volunteers welcome
- Sponsor
- VisDura, Inc.
Chronic Sinusitis
Clinical Evaluation of Propel Nova Sinus Implant in Peripheral Sinus Ostia
This is a feasibility study is to assess the performance, safety and initial signals of efficacy of the drug-eluting Propel Nova Sinus Implant when used in chronic sinusitis patients undergoing sinus surgery of peripheral sinus…
- Trial name
- EXCEED (NCT02228720)
- Testing
- Propel Nova Sinus Implant
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Intersect ENT
Cataract
Visual Outcomes After Cataract Surgery: Multifocal AcrySof® IQ ReSTOR® Intraocular Lenses Versus Monofocal Intraocular Lenses
The purpose of this study is to assess and compare visual outcomes of the AcrySof® IQ ReSTOR® +3.0 D intraocular lens (IOL) to a commercially available monofocal IOL in cataract patients.
- Trial name
- NCT01290068
- Testing
- AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, Monofocal IOL
- Volunteers
- 208 people
- Sponsor
- Alcon Research
Cataract
Accommodation Measurements After Bilateral Implantation of an Aspheric Accommodating Lens and Monofocal Aspheric Lenses
The objective of this study is to demonstrate the correlation of near vision and changes in higher order aberrations following lens extraction and to characterize the defocus curves of Crystalens® AO™ intraocular lens (IOL)…
- Trial name
- NCT01241279
- Testing
- Crystalens AO, SoftPort LI61AO
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Bausch & Lomb Incorporated
Peri-implant Mucositis
The Efficacy of Stabilized Chlorine Dioxide Rinse as a Chemical Adjuvant for Treatment of Per-implant Mucositis
A full understanding of etiology and diagnosis of peri-implant diseases is crucial for finding effective treatments for these diseases that are more widely accessible to dentists.
- Trial name
- NCT04838054
- Testing
- Stabilized chlorine dioxide oral rinse
- Where
- United States
- Volunteers
- 57 people
- Sponsor
- Rowpar Pharmaceuticals, Inc.
Jaw, Edentulous
Study on ASTRA TECH Implant System, OsseoSpeed™ Implants in Patients Missing All Teeth in the Upper Jaw, Restored With Provisional Teeth Within 24 Hours
The purpose of the study is to evaluate ASTRA TECH Implant System, OsseoSpeed™ implants, in patients with totally edentulous upper jaws and poor bone quality and quantity, when provisional artificial teeth are attached within 24…
- Trial name
- NCT00711022
- Testing
- ASTRA TECH Implant System, OsseoSpeed™, all dimensions.
- Where
- 2 sites in United States, Sweden
- Volunteers
- 51 people
- Sponsor
- Dentsply Sirona Implants and Consumables
Cataract
Optimizing the Assessment of Refractive Outcomes After Cataract Surgery
The purpose of this study is to evaluate current available assessments (automated vs. manual) with which manifest refraction data and biometric variables are obtained to understand if data from an automated refractor can be…
- Trial name
- NCT02842151
- Testing
- Manifest refraction, ACRYSOF® IQ Monofocal IOL Model SN60WF, Topcon® KR-1W Wave-Front Analyzer
- Volunteers
- 162 people
- Sponsor
- Alcon Research
Total Knee Arthroplasty (Postoperative Pain)
Phase 2B Study Assessing Pain Relief After Replacement of the Knee
The goal of the ATX101-TKA-004 clinical trial aims to evaluate the efficacy and safety of ATX101 1,500 mg in participants undergoing primary unilateral total knee arthroplasty.
- Trial name
- SPARK2 (NCT06799845)
- Testing
- ATX101, bupivacaine hydrochloride
- Where
- 11 sites in United States
- Volunteers
- 226 people
- Sponsor
- Allay Therapeutics, Inc.
Ocular Hypertension, Open Angle Glaucoma
CLN-0045: Safety, and Efficacy of OTX-TIC in Participants With Open Angle Glaucoma or Ocular Hypertension
To assess the safety, tolerability and efficacy of a single sustained release dose of OTX-TIC, a sustained release travoprost drug product, in subjects with primary open-angle glaucoma or ocular hypertension.
- Trial name
- NCT04360174
- Testing
- OTX-TIC
- Where
- 5 sites in United States
- Volunteers
- 19 people
- Sponsor
- Ocular Therapeutix, Inc.
Diabetic Macular Edema
Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema
This study will evaluate the safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema.
- Trial name
- FAME (NCT00344968)
- Testing
- fluocinolone acetonide, Standard of care laser photocoagulation
- Where
- United States
- Volunteers
- 956 people
- Sponsor
- Alimera Sciences
Hearing Loss
Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
The aim of this clinical investigation is to collect data on objective and subjective hearing performance, quality of life and safety in adult subjects with conductive hearing loss, mixed hearing loss or single-sided…
- Trial name
- NCT04041700
- Testing
- Osia 2 system
- Where
- 3 sites in Australia, Hong Kong
- Volunteers
- 29 people
- Sponsor
- Cochlear
Breast Implantation
Retrospective Study of Incidence and Etiology of Reoperation After Primary Augmentation With Natrelle® Breast Implants
Retrospective multi-center, post-marketing study to evaluate the incidence and etiology of reoperations with Allergan Natrelle® Breast Implants in primary augmentation (RANBI)
- Trial name
- RANBI (NCT02132572)
- Testing
- BIOCELL™ Textured 410 Implant
- Where
- 5 sites in France, Germany and 3 more
- Volunteers
- 201 people
- Sponsor
- Allergan
Macular Edema
Study Assessing AR-1105 in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO)
This study will evaluate the safety, tolerability and efficacy of AR-1105 (dexamethasone implant) for the treatment of macular edema (ME) due to retinal vein occlusion (RVO).
- Trial name
- NCT03739593
- Testing
- AR-1105-CF1, AR-1105-CF2
- Where
- 11 sites in United States
- Volunteers
- 49 people
- Sponsor
- Aerie Pharmaceuticals
Chronic Sinusitis, Nasal Polyposis
Safety Evaluation of Repeat Placement of the S8 Sinus Implant in Chronic Sinusitis Patients With Nasal Polyps (ENCORE)
The ENCORE Study is designed to evaluate the repeat administration of the S8 Sinus Implant in chronic sinusitis (CS) patients with recurrent nasal polyps.
- Trial name
- NCT03358329
- Testing
- S8 Sinus Implant
- Where
- 9 sites in United States
- Volunteers
- 50 people
- Sponsor
- Intersect ENT
Hearing Loss, Sensorineural
Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implant in Adults
The purpose of this study is to gather long-term data on the FDA approved CI532 cochlear implant, and CP1000 (Nucleus 7) sound processor
- Trial name
- SME (NCT03007472)
- Testing
- CI532, Nucleus 7
- Where
- 10 sites in United States
- Volunteers
- 96 people
- Sponsor
- Cochlear
Aortic Stenosis, Valvular Heart Disease
ADVANCE Direct Aortic Study
This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve…
- Trial name
- NCT01676727
- Testing
- CoreValve aortic valve
- Where
- 9 sites in Czechia, France and 4 more
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Primary Open Angle Glaucoma
Safety and Performance of Miami InnFocus Drainage Implant (MIDI Arrow) Glaucoma Drainage Implant
To assess the safety and performance of the MIDI Arrow in patients suffering from glaucoma that is inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 40 mm Hg
- Trial name
- NCT01563237
- Testing
- MIDI Arrow
- Where
- France
- Volunteers
- 69 people
- Sponsor
- InnFocus Inc.
Hearing Loss
Clinical Evaluation of the Nucleus 5 Cochlear Implant (CI) System
To evaluate the performance of the Nucleus 5 Cochlear Implant System.
- Trial name
- NCT01072409
- Testing
- Nucleus 5 Cochlear implant, Cochlear implantation
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Cochlear
Symptomatic Severe Aortic Stenosis
FlexNav EU CE Mark Study
The purpose of this clinical investigation is to characterize the safety of the next-generation FlexNav™ Delivery System for transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in symptomatic severe aortic…
- Trial name
- NCT03724812
- Testing
- Portico Valve and FlexNav™ Delivery System
- Where
- 6 sites in Denmark, Italy and 2 more
- Volunteers
- 46 people
- Sponsor
- Abbott Medical Devices
Articular Cartilage Lesion of the Femoral Condyle
RCT of ChondroCelect® (in an ACI Procedure) vs Microfracture in the Repair of Cartilage Defects of the Knee
This is a phase III, multicenter, open-label, randomized controlled trial of ChondroCelect® in an Autologous Chondrocyte Implantation (ACI) procedure compared to the procedure of microfracture (MF) in the repair of symptomatic…
- Trial name
- TIGACT01 (NCT00414700)
- Testing
- ChondroCelect implantation, Microfracture
- Where
- 12 sites in Belgium, Croatia and 2 more
- Volunteers
- 118 people
- Sponsor
- TiGenix n.v.