Primary Objective: The primary objective of this study is to compare the postoperative visual outcomes in a series of patients bilaterally implanted with the AT LISA tri 839MP IOL versus those bilaterally implanted with the TECNIS® Symfony IOL (…
ID
Source
Brief title
Condition
- Anterior eye structural change, deposit and degeneration
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the binocular uncorrected visual acuity at 80 cm
distance under both photopic and mesopic conditions 13 weeks postoperatively.
Secondary outcome
Secondary endpoints are: binocular (un)corrected visual acuity at far (4
meters) and near (40 cm) under both photopic and mesopic conditions, reading
performance, patient satisfaction, and complication profile.
Background summary
Since the introduction of intraocular lenses (IOL) in the treatment of
cataract, the postoperative accommodative loss of the human eye has been a
trending topic. Numerous studies show a high rate of spectacle-independency
after bilateral implantation of multifocal IOLs (MIOL). However, glare and
halos under different light conditions are common complaints after MIOL
implantation. Due to its unique design, the TECNIS® Symfony IOL (ZXR00) is
theoretically providing a continuous range of high-quality vision for far,
intermediate, and near distances with the same low incidence of halos and glare
associated with monofocal IOLs.
The goal of this study is to compare the AT LISA trifocal 839MP (a commonly
used multifocal IOL) versus the TECNIS® Symfony Extended Range of Vision IOL in
terms of postoperative achieved visual acuity at different distances and
patient satisfaction. So far, there are no published studies comparing both
IOLs. Therefore, we will perform this randomized control trial.
Study objective
Primary Objective:
The primary objective of this study is to compare the postoperative visual
outcomes in a series of patients bilaterally implanted with the AT LISA tri
839MP IOL versus those bilaterally implanted with the TECNIS® Symfony IOL
(ZXR00). Primary outcome measure is the mean binocular uncorrected intermediate
visual acuity at 80 cm under both photopic and mesopic conditions at 13 weeks
(3 months) postoperatively.
Study design
Single-centre randomised clinical trial
Intervention
Cataract surgery with bilateral implantation of either a TECNIS® Symfony
Extended Range of Vision IOL (Symfony IOL, Abbott) or an AT LISA trifocal 839MP
IOL (Zeiss).
Study burden and risks
The pre- and postoperatively examinations to be performed in this study are
part of the regular medical treatment of patients with cataract who need
cataract surgery. There are four postoperative visits, which is one more
compared to standard cataract surgery. Both the TECNIS® Symfony Extended Range
of Vision IOL (Symfony IOL, Abbott) and the AT LISA trifocal 839MP (Zeiss) used
in this study, are CE marked and commercially available in the countries in
which the study will be conducted.
P. Debeyelaan 25
Maastricht 6229 HX
NL
P. Debeyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
- Minimum 21 years of age
- Bilateral cataract
- Bilateral implantation of Tecnis Symfony or AT LISA tri 839 (same lens model in both eyes)
- Expected postoperative astigmatism <= 1.00 D
- IOL power calculation between +10.00 D and 32.00 D
- Expected postoperative best-corrected visual acuity of logMAR +0.3 or better
- Availability to undergo second eye surgery within 2 weeks of the first eye surgery
- Willing and able to comply with scheduled visits and other study procedures
- Signed informed consent
Exclusion criteria
- Previous corneal surgery and/or reshaping
- Clinically significant corneal endothelial dystrophy (e.g., Fuchs* dystrophy)
- Irregular astigmatism
- History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
- Extensive age related macular degeneration (atrophic or exudative age-related macular degeneration or numerous soft drusen)
- Extensive visual field loss (e.g., glaucoma, CVA, etc.)
- Extensive diabetic macular disease
- Amblyopia, strabismus
- Keratoconus
- Pseudoexfoliation syndrome or other capsule or zonular abnormalities that could affect postoperative centration or tilt of the IOL
- Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic/scotopic conditions)
- Suturing of incision required at time of surgery
- Complications during surgery
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| Other | In behandeling |
| CCMO | NL56878.068.16 |