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

NCT07623317 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-06-03

No results posted yet for this study

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.

Conditions

  • Cataract (Post-operative Cataract Surgery Follow-up)
  • Refraction Error

Interventions

PROCEDURE

Adapted clear corneal incisions

For corneal astigmatismus with steep meridian axis in the interval 61-119 degrees, main incision (1.8mm wide) is placed in the steep axis. For astigmatismus larger than 1.5 dioptres, the main incision is enlarged to 2.75mm before placement of intra-ocular lens. For corneal astigmatismus with steep meridian axis in the intervals 0-60 degrees and 120-179 degrees, main incision (1.8mm wide) is placed in the steep axis. Before placement of intra-ocular lens, a corresponding incision is made at the edge of the cornea opposite to (180 degrees from) the primary main incision. For astigmatismus larger than 1.5 dioptres, the main incision is enlarged to 2.75mm before placement of intra-ocular lens, and the opposite incision is made to measure 2.75mm.

Sponsors & Collaborators

  • Linkoeping University

    lead OTHER_GOV

Principal Investigators

  • Björn Johansson, MD PhD FEBO · Department of Biomedical and Clinical Sciences, Division of Sensory Organs and Communication, Medical Faculty of Linköping University, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-15
Primary Completion
2027-03-31
Completion
2027-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07623317 on ClinicalTrials.gov