Cataract Clinical Trial
Official title:
An Open Two-center Study Evaluating the Safety of Hyaluronan Thiomer i.o. Implant During Combined Phacoemulsification - Non Penetrating Deep Sclerectomy in Patients With Open Angle Glaucoma and Cataract
The study is designed to assess the safety of Hyaluronan Thiomer i.o. implant in patients
with primary open angle glaucoma undergoing a combined phacoemulsification - non penetrating
deep sclerectomy procedure.
In this study, Hyaluronan Thiomer i.o. will be implanted during a combined surgery of
cataract and non - penetrating deep sclerectomy in a group of 16 patients with primary open
angle glaucoma and clinically significant cataract. Given that a considerable number of
glaucoma patients also suffer from cataract, it is reasonable to test Hyaluronan Thiomer
i.o. during a combined procedure of phacoemulsification and deep sclerectomy. This is also
of importance because a combined procedure avoids the need of a second operation in this
group of patients. Finally, it has been shown that combined phacoemulsification - deep
sclerectomy does not induce a further risk compared to deep sclerectomy alone(open phase I
study).
Safety will be assessed based on the occurrence of adverse events.
Efficacy assessments will be performed at every visit and efficacy analysis will include:
- Proportion of subjects at each study time point which will need additional IOP lowering
drug therapy to achieve an IOP reduction to values < 21 mmHg. If a subject needs more
than one drug to achieve target IOP, the number of drugs needed to achieve adequate IOP
reduction will be recorded.
- Proportion of subjects at each time point which will need Neodymium:YAG goniopuncture
to achieve an IOP reduction to values < 21 mmHg.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04685538 -
Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification.
|
Phase 3 | |
| Recruiting |
NCT06060041 -
IC-8 Apthera IOL New Enrollment Post Approval Study
|
||
| Recruiting |
NCT05518539 -
Evaluation of Quality of Vision and Visual Outcomes With Bilateral Implantation of the Clareon PanOptix Intraocular Lens
|
||
| Recruiting |
NCT05271942 -
Tilt and Tumble vs Divide and Conquer - a Unique Comparison of the Two Cataract Surgery Methods
|
N/A | |
| Active, not recruiting |
NCT04778501 -
PMCF Study on Monofocal Toric IOL (PODEYE TORIC) in Asia
|
N/A | |
| Completed |
NCT05062564 -
Efficacy of LipiFlow in Patients Affected by Meibomian Gland Dysfunction in Reducing Post-cataract Surgery Dry Eye
|
N/A | |
| Completed |
NCT03751033 -
Influence of DisCoVisc Ophthalmic Viscosurgical Device (OVD) on Intraoperative Aberrometry Readings
|
N/A | |
| Completed |
NCT02529488 -
Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting Intraocular Lens (IOL) Model TFNT00
|
N/A | |
| Completed |
NCT04539548 -
A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract
|
Phase 3 | |
| Completed |
NCT03740659 -
Evaluation Of Aqueous Humor Of Levofloxacin-Dexamethasone Eye Drops And Of Its Components In Patients Undergoing Cataract Surgery
|
Phase 2 | |
| Completed |
NCT03494257 -
Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification
|
N/A | |
| Completed |
NCT05119127 -
Rotational Stability of Acrysof IQ Vivity Extended Vision Toric IOL and Refractive Visual Outcome.
|
N/A | |
| Active, not recruiting |
NCT04271709 -
Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT)
|
N/A | |
| Recruiting |
NCT03713268 -
Intraoperative OCT Guidance of Intraocular Surgery II
|
||
| Completed |
NCT03739528 -
Levo-Dexa vs. Tobra+Dexa for Prevention and Treatment of Inflammation and Prevention of Infection in Cataract Surgery
|
Phase 3 | |
| Completed |
NCT02888210 -
A Study Assessing Safety and Efficacy of MD-15 Intraocular Lens in Patients With Aphakic Eye After Cataract Surgery
|
Phase 3 | |
| Completed |
NCT03356847 -
Evaluation of the Rotational Stability of the Monofocal SISA Implant Following Cataract Surgery
|
N/A | |
| Completed |
NCT04332640 -
Clinical Evaluation of the Next Generation Phaco System
|
N/A | |
| Recruiting |
NCT03638726 -
Subconjunctival Atropine and Intracameral Epinephrine for Pupil Dilation in Phacoemulsification
|
Phase 4 | |
| Completed |
NCT03050697 -
Evaluation of the Safety and Performance of the HARMONI® Toric Lens
|
N/A |