The aim of this research is to find out which lens gives the best results.
ID
Source
Brief title
Condition
- Eye disorders
- Eye therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The measurement of uncorrected and corrected intermediate visual acuity is the
primary endpoint of this study in which the Tecnis Eyhance IOL and the Hoya
Vivinex IOL are compared
Secondary outcome
NA
Background summary
With an estimated number of cataract extractions of 180.000 per year in the
Netherlands, cataract surgery is one of the most frequently performed types of
surgery.
Monofocal IOLs are the most implanted IOLs in cataract surgery and are the
standard of care for reimbursed cataract procedures by health insurance
companies. Using a reliable IOL plat-form with a monofocal lens that meets the
highest standards of care is therefore the ultimate goal in selecting the right
IOL. It*s therefor important to compare current monofocal IOL plat-forms that
are being used nowadays for its effectiveness in standard cataract surgery. In
this study we want to compare the Vivinex iSert© IOL (HOYA) to the newly
introduced Tecnis Eyhance© IOL (Johnson & Johnson Vision).
Our hypothesis is that the new Eyehance iol performes better for intermediate
visual acuity and has a flatter defocuscurve profile than the Vivinex iol which
may result in more patients being independent of spectacle wear after standard
cataractsurgery
Study objective
The aim of this research is to find out which lens gives the best results.
Study design
Single center, prospective, comparative, randomised clinical trial
Intervention
Cataract surgery using phacoemulsification in both eyes during two separate
operations (operation session 1: eye 1, operation session 2: eye 2), where
there is a minimum of two weeks between both operation sessions (is standard
procedure). Randomization determines which lens is used, the Vivinex iSert IOL
(control product) or the Tecnis Eyhance IOL (test product).
Study burden and risks
Potential benefits: the Eyehance lens has the potential to deliver more
spectacle independan-ce for intermediate visual acuity than the Vivinex iol.
Potential risks associated with participation are the possible complications of
cataract surgery in general, most importantly the very rare but severe risk of
endophthalmitis (ocular infection) and the risk of refractive surprise (a
significant deviation from the predicted refraction). The risk on facing one of
these complications is similar for both eyes, regardless of the time of
surgery. Compared to usual care, the extra burden for all patients
participating in this study is filling in questionnaires two times during the
study, which will take about 15 minutes per time.
Hilvarenbeekseweg 60
Tilburg 5022 GC
NL
Hilvarenbeekseweg 60
Tilburg 5022 GC
NL
Listed location countries
Age
Inclusion criteria
- Bilateral cataract
- Expected uncomplicated cataract surgery
Exclusion criteria
- Age < 18 years
- Insufficient understanding of the Dutch language to comply with study
procedures and/or complete patient questionnaires
- Inability to complete follow-up or comply with study procedures
- Non-routine cataract surgery (e.g., cataract surgery combined with another
ocular procedure, cataract surgery under general anesthesia)
- Cognitive or behavioral conditions that might interfere with surgery
- Cataract surgery with premium IOL implantation (i.e., toric IOLs, multifocal
IOLs)
- Conditions that increase the risk of endophthalmitis:
* Current ocular, adnexal, or periocular infections (e.g., untreated
blepharitis)
* Immune-compromised (e.g., systemic corticosteroid use, leukaemia)
* Iodine allergy
- Factors that increase the risk of refractive surprise:
* Abnormal axial lengths (< 21 mm or > 27 mm) or a difference between both eyes
of > 1.5 mm
* Abnormal keratometry readings
* Previous refractive surgery
* Myopia with posterior staphylomas
- Conditions that increase the risk of corneal edema (e.g., Fuchs* endothelial
dystrophy)
- Factors that increase the risk of complicated surgery:
* Previous ocular surgery
* Previous perforating or blunt eye trauma
* Eye, adnexal, or anatomical abnormalities (including pseudoexfoliation
syndrome)
* Lens luxation or iridodonesis
* Cataract nigrans, posterior polar cataract
- Sight-threatening comorbidity
- Glaucoma or intraocular pressure of > 24 mmHg
- Uveitis
- Diabetes mellitus with diabetic retinopathy and macular edema.
- Any Macular disease
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL70320.028.19 |