The primary aim is to evaluate the effectiveness of bilateral toric IOL implantation versus bilateral monofocal IOL in patients that undergo cataract surgery and have a predicted residual refractive astigmatism >=0.75 and
ID
Source
Brief title
Condition
- Vision disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the mean UDVA of the toric IOL group after
cataract operations compared to the non-toric IOL group.
Secondary outcome
Secondary study parameters/endpoints are:
- Cost-effectiveness: multi-country short-term trial-based economic evaluation
(TBEE) and long-term model-based economic evaluation (MBEE);
- The proportion of eyes that achieve postoperative refractive astigmatism <=
0.50 D
- Spectacle independence for distance;
- The proportion of eyes that achieve UDVA >=20/25 and 20/30;
- Prediction accuracy of mathematical models (that estimate the TCA) vs direct
measurements of the TCA in mild PEA;
- Change in PROMs from preoperative to 12 weeks postoperative;
- The achieved level of reduced activity limitations after surgery;
- Patient satisfaction with vision.
Background summary
Annually, 180.000 cataract surgeries are performed in the Netherlands. One in
two patients undergoing this operation, have mild astigmatism (>=0.75 en
<=1.50D). Uncorrected astigmatism can cause decreased vision, reading problems,
and problems with night-time driving. Implantation of a toric intraocular lens
(IOL) can decrease the astigmatism after the operation. In patients with
moderate and severe astigmatism (>=1.50 dioptre (D)), there is high-level
evidence that toric IOL provide better uncorrected distance visual acuity
(UDVA), greater spectacle independence, and lower amounts of residual
astigmatism than non-toric IOLs. However, there are no complete and undisputed
results in the literature on the efficacy of toric IOLs in patients with mild,
clinically relevant astigmatism (>=0.75D and <=1.50D), affecting the majority of
cataract patients. We hypothesize that in patients with bilateral cataract and
mild regular total corneal astigmatism in the range >=0.75D to <=1.50D, toric
lenses result in better-uncorrected intended visual acuity compared to standard
lenses.
Study objective
The primary aim is to evaluate the effectiveness of bilateral toric IOL
implantation versus bilateral monofocal IOL in patients that undergo cataract
surgery and have a predicted residual refractive astigmatism >=0.75 and <=1.50D.
Study design
The study design is a multinational, single-blinded, clinical randomized
controlled trial (RCT) with a duration of 36 months.
Intervention
The intervention group will receive bilateral phacoemulsification with toric
IOLs. The control group will receive bilateral phacoemulsification with
non-toric monofocal IOLs. Patients and investigators will be blinded to the
intervention allocation.
Study burden and risks
All intraocular lenses used in this study have a Conformité Européenne (CE)
marking and are commercially available. Standard phacoemulsification techniques
will be used to implant both types of IOLs. Most measurements and examinations
in this study are part of the regular medical treatment of patients with
astigmatism who need cataract surgery. All additional examinations are
non-invasive. The study will include one extra visit twelve weeks after the
cataract surgery.
P. Debyelaan 25
Maastricht 6229HX
NL
P. Debyelaan 25
Maastricht 6229HX
NL
Listed location countries
Age
Inclusion criteria
- Bilateral cataract for which uneventful phacoemulsification and IOL
implantation is planned;
- Predicted residual refractive astigmatism of >=0.75 to <=1.50D in both eyes
assessed by IOLMaster 700;
Exclusion criteria
- Irregular astigmatism or abnormal corneal topography;
- Previous intraocular or corneal (refractive) surgery;
- Hard contact lens wear;
- Dilated pupillary diameter smaller than 6 mm;
- Projected corrected visual acuity higher than 0.2 logMar (lower than 0.63
decimal);
- Visual limiting ocular comorbidity: e.g. macular pathology, uncontrolled
glaucoma;
- Traumatic cataract or pseudoexfoliation;
- Target refraction other than emmetropia;
- Require an IOL that is not within the available power range of the
manufacturer;
- Pregnancy (current and planned) or lactation;
- Patients participating in another drug or device investigation;
- Unavailable to undergo second eye surgery within two weeks of first eye
surgery;
- Patients unable to consent or complete follow-up visits.
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 |
|---|---|
| CCMO | NL75080.068.20 |