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VISPER: Randomised Comparison of Two OVDs in Cataract Surgery (VISPER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04252716
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Carl Zeiss Meditec AG

Brief 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

Condition or disease Intervention/treatment Phase
Cataract Senile Device: OVD Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Multi-centre, Observer-masked, Non-inferiority Comparison of Two Cohesive Viscoelastic Solutions: VISTHESIA v Provisc
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: VISTHESIA 1.5 Device: OVD
Space creation in the anterior chamber, Endothelial Protection and Control of Intraocular Pressure during Phacoemulsification Cataract Surgery

Active Comparator: ProVisc Device: OVD
Space creation in the anterior chamber, Endothelial Protection and Control of Intraocular Pressure during Phacoemulsification Cataract Surgery




Primary Outcome Measures :
  1. Frequency of incidence of Intraocular Pressure greater than or equal to 30 mm Hg, [ Time Frame: 6-hours post-operatively ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.)
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Responsible Party: Carl Zeiss Meditec AG
ClinicalTrials.gov Identifier: NCT04252716    
Other Study ID Numbers: Visth 1.5 BER-401-19
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases