Clinical trials: Inlays
Presbyopia
Safety and Efficacy of an Intrastromal Transform™ Corneal Allograft (TCA) for Presbyopia Correction
The objective of this clinical study is to evaluate the safety and effectiveness of intrastromal implantation of the Allotex TransForm corneal allograft (TCA) for improving near vision in presbyopic subjects.
- Trial name
- NCT03671135
- Testing
- TCA Intrastromal Inlay
- Where
- 4 sites in Belgium, Ireland and 1 more
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Allotex, Inc.
Presbyopia
Safety and Effectiveness Study of the AcuFocus Corneal Inlay ACI 7000PDT in Presbyopes
The purpose of this study is to determine if the AcuFocus Corneal Inlay ACI 7000PDT will provide an effective method for the correction of presbyopia in patients who have normal distance vision but need a correction such as…
- Trial name
- ACI (NCT00850031)
- Testing
- AcuFocus Corneal Inlay
- Where
- 8 sites in Australia, Austria and 4 more
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- AcuFocus, Inc.
Parastomal Hernia
Parastomal Reinforcement With Strattice
The purpose of this study is to compare the clinical outcomes of patients undergoing surgery for a permanent abdominal wall ostomy with and without placement of Strattice fascial inlay, as measured by postoperative occurence of…
- Trial name
- PriSm (NCT00771407)
- Testing
- Strattice Reconstructive Matrix, Standard ostomy creation
- Where
- 23 sites in United States
- Volunteers
- 120 people
- Sponsor
- LifeCell
Restoration of Posterior Teeth
Clinical Evaluation of Chairside CAD/CAM Nano-ceramic Restorations
Study aim is to test whether nano-composite CAD/CAM milled restorations have a similar performance in clinical service to conventional ceramic CAD/CAM restorations.
- Trial name
- NCT01464294
- Testing
- Milled ceramic restorations, Milled nano-composite restorations
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Solventum US LLC
Craniotomy, Duraplasty
Assessment of the Performance of LYoplant® ONlay for Duraplasty
The aim of this Post Market Clinical Follow-up Study is to collect clinical data on the performance of Lyoplant® Onlay. To assess the performance of the product, various safety and efficacy parameters have been selected.
- Conditions
- Craniotomy, Duraplasty, Spinal Surgery
- Trial name
- LYON (NCT02678156)
- Testing
- Lyoplant Onlay
- Where
- 3 sites in Germany
- Volunteers
- 61 people
- Sponsor
- Aesculap AG
Repair of Dura Mater
Post-Market Clinical Investigation Plan- Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus)
Monitoring the Use of Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus) in the Postmarket Phase.
- Trial name
- NCT06802133
- Testing
- Post Market Study
- Where
- 2 sites in United States
- Volunteers
- 118 people
- Sponsor
- Collagen Matrix
Replacement and Extension of Connective Tissue Structure in Neurosurgery
The Efficacy and Safety of Lyoplant® Onlay in Repairing Cerebral Dura Mater
Objective of this clinical trial is to compare the safety and efficacy of Mianfengxing Kexishou Yingmo Bupian(Lyoplant® Onlay) and Yingmo Bupianfor dural repair.270 subjects will be enrolled for this study.
- Trial name
- NCT03951272
- Testing
- Lyoplant® Onlay/DURAFORM™ Dural Graft Implant
- Where
- China
- Volunteers
- 240 people
- Sponsor
- B. Braun Medical International Trading Company Ltd.
Patient-Reported Outcomes (PRO)
Qualitative Validation of Patient-Reported Outcomes (PRO) Instrument
The purpose of this study is to conduct concept elicitation and cognitive debriefing interviews with patients who have been implanted with the KAMRA inlay in order to assess the content validity of a PRO instrument
- Trial name
- NCT03536715
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- AcuFocus, Inc.
Presbyopia
Safety and Effectiveness Study of the AcuFocus Corneal Inlay ACI 7000PDT in Presbyopes
The purpose of this study is to determine if the AcuFocus Corneal Inlay ACI 7000PDT will provide an effective method for the correction of presbyopia in patients who have normal distance vision but need a correction such as…
- Trial name
- ACI (NCT00819299)
- Testing
- AcuFocus Corneal Inlay ACI 7000PDT
- Where
- 15 sites in United States
- Volunteers
- 359 people, healthy volunteers welcome
- Sponsor
- AcuFocus, Inc.
Presbyopia
A Clinical Trial to Evaluate a Corneal Inlay for the Improvement of Near Vision in Presbyopic Patients
This study will be a prospective, multicenter clinical trial in which a total of 400 subjects will be enrolled. All subjects will be followed over a 36 month time frame with a maximum of 15 clinical sites participating.
- Trial name
- NCT01373580
- Testing
- The Raindrop Near Vision Inlay
- Where
- 11 sites in United States
- Volunteers
- 373 people, healthy volunteers welcome
- Sponsor
- ReVision Optics, Inc.
Presbyopia
Evaluation of Safety and Efficacy of Intrastromal Implantation of CorVision® Bioengineered Corneal Inlay for Correction of Presbyopia.
This clinical investigation is a prospective, multicentre, non-comparative case series to assess safety and efficacy of CorVision® bioengineered corneal inlay for improving uncorrected near vision in presbyopic subjects.
- Trial name
- CorVision (NCT04465409)
- Testing
- Intrastromal implantation of CorVision bioengineered corneal inlay for correction of presbyopia.
- Where
- Czechia
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- LinkoCare Life Sciences AB
Presbyopia
A Clinical Trial to Evaluate the Safety and Effectiveness of the Raindrop Near Vision Inlay for Pseudophakic Subjects
The objective of this study is to evaluate the safety and effectiveness of the Raindrop Near Vision Inlay implanted in bilateral pseudophakes with presbyopia for improvement of near and intermediate vision.
- Trial name
- NCT03017612
- Testing
- Raindrop Near Vision Inlay
- Where
- 6 sites in United States
- Volunteers
- 13 people
- Sponsor
- ReVision Optics, Inc.
Single Tooth Restoration, Longevity
Clinical Evaluation on the Longevity of Glass Ceramic Based Single Tooth Restorations
This retrospective study investigates the longevity of lithium disilicate based glass-ceramic single tooth restorations placed with IPS e.max CAD and IPS e.max Press after a wearing period of more than 15 years.
- Trial name
- NCT06898411
- Testing
- Single tooth restoration with IPS e.max
- Where
- Liechtenstein
- Volunteers
- 56 people
- Sponsor
- Ivoclar Vivadent AG
Presbyopia
Post-Approval Study With the KAMRA Inlay
KAMRA inlay, to be unilaterally implanted into the cornea of a subject's non-dominant eye. The inlay is to be inserted into a stromal pocket created with a surgical femtosecond laser.
- Trial name
- NCT03173664
- Testing
- KAMRA Inlay
- Volunteers
- 529 people, healthy volunteers welcome
- Sponsor
- AcuFocus, Inc.
Presbyopia, Pseudophakia
A Clinical Trial to Evaluate a Corneal Inlay for the Improvement of Near and Intermediate Vision in Pseudophakic Presbyopic Subjects
The objective of this study is to evaluate the safety and effectiveness of the Raindrop Near Vision Inlay implanted in bilateral pseudophakes with presbyopia for improvement of near and intermediate vision.
- Trial name
- NCT02668523
- Testing
- Raindrop Near Vision Inlay
- Where
- 13 sites in United States
- Volunteers
- 400 people
- Sponsor
- ReVision Optics, Inc.
Cataract, Presbyopia
IOL Implantation After KAMRA Inlay Removal
A. The primary purpose of the study is to evaluate outcomes of aphakic eyes implanted with the IC-8 IOL following cataract removal in prior inlay patients after KAMRA inlay removal. B.
- Trial name
- NCT03320473
- Testing
- IC-8 IOL
- Where
- Philippines
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- AcuFocus, Inc.
Presbyopia
Safety and Effectiveness of the AcuFocus Corneal Inlay ACI7000PDT in Presbyopes
The purpose of this study is to determine if the AcuFocus Corneal Inlay ACI 7000PDT will provide an effective method of for the correction of presbyopia in patients who have normal distance vision but need correction such as…
- Trial name
- NCT01352442
- Testing
- AcuFocus Corneal Inlay ACI 7000PDT
- Where
- 11 sites in Australia, Austria and 8 more
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- AcuFocus, Inc.