Can Tailored Surgical Incisions Reduce Refractive Error and Dependence on Glasses After Cataract Surgery?

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-90
SponsorLinkoeping University

About this trial

Astigmatism is a common cause of continued dependence on glasses after cataract surgery and may lead to patient dissatisfaction with surgical outcomes. As the corneal curvature is the main source for astigmatism after cataract surgery, our aim is to investigate whether postoperative astigmatism can be reduced by tailoring the location of surgical incisions according to the curvature of the cornea. We also wish to investigate whether this in turn reduces the need for glasses following cataract surgery.

In the planned study, one group of patients with cataracts and concurrent corneal astigmatism will undergo surgery using customized incision placement, while a control group will be operated on using standard incision placement without consideration of corneal astigmatism. Astigmatism will be measured before surgery and again at 3 and 12 weeks postoperatively. We will also assess how tailored incisions affect corneal biomechanics and shape, as well as measure visual quality and the need for glasses during daily activities before and after surgery.

Approximately 160,000 cataract procedures are performed annually in Sweden. Around 40% of these patients (64,000 individuals) have astigmatism greater than 1 diopter and could potentially achieve improved surgical outcomes based on the results of this study. The method is cost-effective and associated with a low risk of complications compared to other approaches for reducing astigmatism.

Eligibility criteria

Qualifiers

Visually disturbing cataract

Corneal and refractive astigmatismus more than 1 dioptre

Able and willing to undergo study procedures and measurements 3 weeks and 12 weeks after cataract surgery.

Disqualifiers

Declining to participate

concomitant disease that prevents detailed objective and subjective investigations (e.g. dementia, serious ocular comorbidity limiting expected postoperative visual acuity to below 20/40)

condition damaging structural integrity of cornea (surgical complications, infection, trauma, previous corneal disease)

Trial design

Treatments tested in this trial

  • Adapted clear corneal incisions

Treatment groups

100 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators