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NCT07623317
Can Tailored Surgical Incisions Reduce Refractive Error and Dependence on Glasses After Cataract Surgery?
Conditions: Cataract (Post-operative Cataract Surgery Follow-up), Refraction Error
Sex: All
Ages: 40 Years – 90 Years
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Linkoeping University
Summary
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
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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)
Source: ClinicalTrials.gov (NCT07623317). StuddyBuddy aggregates publicly available trial information.
