Visual Outcome, Cylinder Correction and Patient Satisfaction After Implantation of AT LISA Tri Toric 939MP Intraocular Lenses
VICTORI
Prospective Study to Evaluate the Visual Outcome, Cylinder Correction and Patient Satisfaction After Implantation of AT LISA Tri Toric 939MP Intraocular Lenses
1 other identifier
interventional
120
0 countries
N/A
Brief Summary
The aim of the present study is to evaluate the postoperative visual acuity for distance, intermediate and near vision as well as the cylinder correction and the patient satisfaction after bilateral implantation of AT LISA tri toric 939MP IOLs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2013
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 5, 2016
CompletedFirst Posted
Study publicly available on registry
December 7, 2016
CompletedJanuary 29, 2018
January 1, 2018
3.3 years
December 5, 2016
January 25, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Best distance-corrected visual acuity for intermediate vision after bilateral implantation
12 months after surgery
Study Arms (1)
939MP
EXPERIMENTALAT LISA tri toric 939MP intraocular lens
Interventions
Eligibility Criteria
You may qualify if:
- Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent
- Man or woman, over 50 years of age
- Healthy eyes with bilateral cataract requiring surgical treatment for both eyes
- Bilateral regular corneal astigmatism (confirmed by topography measurement)
- Only patients requiring intraocular lenses of a power comprised between sphere +0.0 and +28.0 dioptres and between a cylindrical range of +1.0 to +4.0D in both eyes will be able to participate in the trial.
- Biometry measurement/cataract density compatible with the IOLMaster evaluation
- Bilateral uncomplicated cataract surgery and implantation into capsular bag by injector
- Assured follow-up examinations
You may not qualify if:
- Patients unable to meet the limitations of the protocol or likely of non cooperation during the trial,
- Patients whose freedom is impaired by administrative or legal order,
- Monophtalmic patient.
- Previous ocular surgery, including corneal/refractive surgery,
- Chronic or recurrent uveitis,
- Acute ocular disease or external/internal infection,
- Any kind of macular degeneration and impairment of retina (clinical diagnosis/OCT examination)
- Diabetes with retinal changes,
- Pseudoexfoliation syndrome
- Pathologic myosis
- Irregular astigmatism, especially keratoconus,
- Endothelial corneal dystrophy
- Glaucoma or IOP higher than 21mmHg under ocular hypertension treatment
- Aniridia
- Pseudophakia
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Piovella, Dr
CMA - Centro Microchirurgia Ambulatoriale
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2016
First Posted
December 7, 2016
Study Start
March 1, 2013
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
January 29, 2018
Record last verified: 2018-01