Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04252716
Other study ID # Visth 1.5 BER-401-19
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 24, 2020
Est. completion date February 8, 2022

Study information

Verified date March 2023
Source Carl Zeiss Meditec AG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To investigate that VISTHESIA 1.5 is non-inferior to Provisc with regards to elevation in IOP greater than or equal to 30 mm Hg 6 ± 2 hours post-operatively as per methodology set out in EN ISO 15798:2013 (Primary Endpoint) To compare the changes in endothelial cell count and incidences of intraocular inflammation between VISTHESIA and Provisc as per methodology set out in EN ISO 15798:2013


Recruitment information / eligibility

Status Completed
Enrollment 273
Est. completion date February 8, 2022
Est. primary completion date November 24, 2021
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: 1. Patients of any gender, 50 years of age or older at the time of study enrolment 2. undergoing age-related cataract removal (phacoemulsification) and IOL implantation in one eye only 3. Patient informed of the needs and visit schedule required of the Clinical Investigational Plan and who has given his/her written informed consent 4. Planned implantation of the IOL in the capsular bag Exclusion Criteria: 1. Patients not able to / willing to give informed consent 2. Patients not able to comprehend and comply with study requirements 3. Patients scheduled for surgery to the fellow eye within 48 hrs preceding any scheduled study follow up. (Surgery date could be changed) 4. Patients not able to attend follow-up appointments for any reason 5. Patients with known hypersensitivity to anaesthetics of the amide type or hyaluronan 6. Patients with reduced corneal endothelium (e.g. Fuch's dystrophy) 7. Patients with epilepsy, impaired cardiac conduction, bradycardia, or impaired respiratory function 8. Patients being treated with tocainide for cardiac arrhythmia 9. Patients with impaired hepatic function, if the anaesthetic dose or site of application is likely to result in high blood levels 10. Mono-ophthalmic patients 11. Patients who have previously undergone cataract surgery in the contralateral eye 12. Patients with any psychosocial, or other chronic disease conditions that may affect the perception of bodily pain 13. VISTHESIA (topical and intracameral components) or ProVisc is not a suitable device for the patient for any reason 14. Patients with other pathology or condition presenting, according to the investigator opinion, a risk for the patient (to be documented in screen log) 15. Female patients who are menstruating, pregnant, breastfeeding or amenorrheic for less than 2 years at the time of surgery 16. Patients who may require the use of hyaluronidase as part of the study cataract procedure 17. Patients who may be regarded as being vulnerable (e.g. prisoners, residents of care or mental health institutions, trauma, war or disaster victims, dependent on the investigator etc.)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
OVD
Intraocular administration

Locations

Country Name City State
Germany University hospital Freiburg Freiburg Baden-Württemberg

Sponsors (1)

Lead Sponsor Collaborator
Carl Zeiss Meditec AG

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary IOP Frequency of incidence of Intraocular Pressure greater than or equal to 30 mm Hg 6-hours post-operatively
See also
  Status Clinical Trial Phase
Completed NCT04998409 - Evaluation of a Spherical Hydrophilic Acrylic Intraocular Lens
Recruiting NCT05110222 - Cataract Lens Hardness Based on Phaco Tip Resistance
Recruiting NCT04266847 - Prospective Clinical Study of Preoperative and Postoperative Unilateral Mild Cataract Patients N/A
Recruiting NCT04175951 - Tecnis Eyhance Versus Rayner RayOne Study N/A
Recruiting NCT04572334 - Eyhance Autorefraction Study N/A
Completed NCT04140383 - Cataract Surgery In Patients With Advanced Age
Active, not recruiting NCT04570579 - Impact of a Novel Extended Depth of Focus Intraocular Lens on Visual and Lifestyle Enhancement
Completed NCT05347615 - Achieving Hybrid Monovision By Paring Monofocal And EDOF Lens Technology
Completed NCT05129566 - Evaluation of Axial Stability of Two Models of Intraocular Lenses in Patients With an Eye Length More Than 26 mm N/A
Recruiting NCT05148507 - Optimization of the Ocular Surface Prior to Cataract Surgery Using PROKERA N/A
Completed NCT04655274 - Comparision of Visual Outcomes and Patient Satisfaction Between Two Diffractive Trifocal Intraocular Lenses
Completed NCT04255706 - Repeatability in Measurements of Two ssOCT and One OLCR Biometer N/A
Completed NCT05287269 - Ocular Coherence Tomography During Cataract Assessment
Completed NCT04545671 - Evaluation of a Trifocal Lens
Completed NCT04580550 - Axial Length Variability N/A
Recruiting NCT04265846 - Prospective Clinical Study of Different Intraocular Lens Implantation Designed for the Correction of Presbyopia
Not yet recruiting NCT06429527 - Vision Test App and Questionnaire for 1-Week Post-Cataract Surgery Follow-Up: A Multi-Center Randomized Controlled Trial N/A
Completed NCT03970525 - Venturi and Peristaltic Based Phacoemulsification in Femtosecond Laser Cataract Surgery
Completed NCT04333056 - Comparison Between Two Ss-OCT Biometry
Completed NCT05578339 - Predicting the Lens Capsular Bag Size Using Pre-operative Biometry N/A