M.M. Dickman, MD, PhD. Ophthalmologist
University Eye Clinic Maastricht UMC+
Maastricht University Medical Center+
SUMMARY
Rationale
Cataract surgery provides a unique opportunity to correct refractive error. In patients with moderate and severe astigmatism (≥1.50 dioptre (D)), there is high-level evidence that toric intraocular lenses (IOLs) 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), which affects the majority of cataract patients.
We hypothesize that in patients with bilateral cataract and mild regular total corneal astigmatism in the range of ≥0.75D to ≤1.50D, toric lenses result in better uncorrected intended visual acuity compared to standard lenses.
Objective
The primary objective of this study is to evaluate the effectiveness of bilateral toric IOL implantation versus bilateral monofocal IOL implantation in patients undergoing cataract surgery who have total corneal astigmatism of ≥0.75D and ≤1.50D.
Study Design
This study is a multinational, single-blinded, randomized controlled clinical trial (RCT) with a total duration of 36 months.
Study Population
The study population will consist of 198 patients aged 21 years or older with mild pre-existing astigmatism (PEA) (≥0.75D to ≤1.50D) undergoing routine cataract surgery.
Intervention
Participants in the intervention group will receive bilateral phacoemulsification with toric IOL implantation.
The control group will undergo bilateral sequential phacoemulsification with non-toric monofocal IOLs.
All patients will be targeted to emmetropia.
Main Study Parameters / Endpoints
The primary endpoint is the mean uncorrected distance visual acuity (UDVA) of the toric IOL group at two and twelve weeks after completion of both cataract operations, compared with the non-toric IOL group.
Nature and Extent of the Burden and Risks Associated with Participation, Benefit, and Group Relatedness
All intraocular lenses used in this study have a Conformité Européenne (CE) marking and are commercially available. Standard phacoemulsification techniques will be used for implantation of both IOL types.
Most measurements and examinations performed in this study are part of routine clinical care for patients with astigmatism undergoing cataract surgery. All additional examinations are non-invasive and are not associated with side effects. The study includes one additional follow-up visit at twelve weeks after cataract surgery.