NCT05596682
Recruiting
Not Applicable
Prospective Multicenter Clinical Study on the Visual and Refractive Outcomes and Safety Outcomes Following Implantation of an AddOn Intraocular Lens in Previously Pseudophakic Eyes
Medicontur Medical Engineering Ltd4 sites in 4 countries75 target enrollmentOctober 17, 2022
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Presbyopia
- Sponsor
- Medicontur Medical Engineering Ltd
- Enrollment
- 75
- Locations
- 4
- Primary Endpoint
- Distance Corrected Near Visual Acuity (DCNVA)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this prospective multicenter clinical study is to evaluate the visual and refractive outcomes and safety outcomes following bilateral implantation of trifocal and/or trifocal toric 1stQ AddOn (Medicontur) intraocular lenses (IOLs) to correct residual refractive errors, astigmatism, and presbyopia in previously pseudophakic eyes.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The subject must read and sign the Informed Consent form.
- •The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •Adult males or females above 18 years of age.
- •No other ocular co -morbidity (i.e. no history of ocular surface disease, severe dry eye, glaucoma, retinal or macular pathology)
- •Pseudophakia.
- •Uncomplicated cataract surgery or clear lens extraction followed by an uneventful recovery period of at least 3-months.
- •Stable primary IOL located in the capsular bag.
- •Anterior chamber depth (ACD) of at least 2.8 mm (measured from corneal endothelium to the anterior surface of the primary IOL in the capsular bag with an optical biometer \[Lenstar, IOL Master\]).
- •Subjects with residual refractive error that is suitable for correction with a secondary add-on IOL.
- •Subjects, who have stable post-operative refraction at month two following uncomplicated primary lens surgery.
Exclusion Criteria
- •Currently pregnant or lactating.
- •Prisoners or young offenders in custody
- •Adults lacking capacity to consent for themselves
- •Phakic or aphakic status.
- •Narrow angle, i.e. \< Schaefer grade 2
- •Pseudophakic patients with malpositioned, subluxated or unstable capsular fixated intraocular lens.
- •Patients with a multifocal capsular bag fixated IOL.
- •Inability to achieve secure placement in the designated location e.g. due to absence of a secure peripheral anterior capsule, absence of intact zonules, or irregular anatomy of the ciliary sulcus.
- •Active ocular diseases (chronic severe uveitis, proliferative diabetic retinopathy, chronic glaucoma not responsive to medication, iris atrophy, severe zonulopathy, pigment dispersion syndrome).
- •Corneal abnormalities such as Unstable Keratoconus, irregular astigmatism.
Outcomes
Primary Outcomes
Distance Corrected Near Visual Acuity (DCNVA)
Time Frame: 6 months
Monocular and binocular DCNVA changes at 6 months after IOLs implantation in comparison to Baseline.
Secondary Outcomes
- Uncorrected Distance Visual Acuity (UDVA)(12 months)
- Distance Corrected Near Visual Acuity (DCNVA)(12 months)
- Uncorrected Intermediate Visual Acuity (UIVA)(12 months)
- Corrected Distance Visual Acuity (CDVA)(12 months)
- Uncorrected Near Visual Acuity (UNVA)(12 months)
- Distance Corrected Intermediate Visual Acuity (DCIVA)(12 months)
Study Sites (4)
Loading locations...
Similar Trials
Active, not recruiting
Not Applicable
Visual Performance of Patients Implanted With a Multifocal IOLCataractRefractive Lens ExchangeNCT06111222Carl Zeiss Meditec AG87
Completed
Not Applicable
Comparative Analysis of the Visual Performance and Patient Satisfaction After Cataract Surgery With Implantation of a Medicontur Monofocal (877PAY) or a Medicontur Extended Depth of Focus (877PEY) IOLCataractPresbyopiaAmetropiaNCT06642779Medicontur Medical Engineering Ltd64
Not yet recruiting
Not Applicable
Myopia Prevention Through Monitoring and Motivating Outdoor Activities With SmartwatchesMyopia, ProgressiveNCT05760911Shanghai Eye Disease Prevention and Treatment Center1,200
Completed
Not Applicable
Clinical Study to Evaluate the RxSight Light Adjustable Lens With the Light Delivery Device in Subjects With Preoperative Corneal AstigmatismCataractNCT03771352RxSight, Inc.55
Terminated
Not Applicable
A Clinical Study to Evaluate The Safety and Effectiveness of The RxSight Light Adjustable Lens (LAL) In Subjects Desiring an Extended Depth of FocusAphakiaCataractPresbyopiaNCT04177771RxSight, Inc.34