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

NCT07623317 | Not Yet Recruiting

• 2 other identifiers: AST-2-LiUogonclin192012
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

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

Keywords

Cataract; Micro-Incision Cataract Surgery; Astigmatismus; Spectacle dependence

Outcome Measures

Primary Outcomes (1)

• Corneal astigmatismus

  Magnitude and axis of corneal astigmatismus

  3 and 12 weeks after cataract surgery

Study Arms (2)

Micro-Incision Cataract Surgery (MICS) with standardized surgical incisions

NO INTERVENTION

Main incision (1.8mm wide) is placed at the edge of the cornea, in an angle of 170 degrees (90 degrees is at 12 o´clock position, upwards). A minimal sideport is created at the edge of the cornea, approximately 90 degrees from the main incision.

MICS with surgical incisions tailored according to corneal astigmatismus

EXPERIMENTAL

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.

Procedure: Adapted clear corneal incisions

Interventions

Adapted clear corneal incisions PROCEDURE

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.

MICS with surgical incisions tailored according to corneal astigmatismus

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Linkoeping University: lead

Related Publications (3)

• Simons RWP, Visser N, van den Biggelaar FJHM, Nuijts RMMA, Webers CAB, Bauer NJC, Beckers HJM, Dirksen CD. Trial-based cost-effectiveness analysis of toric versus monofocal intraocular lenses in cataract patients with bilateral corneal astigmatism in the Netherlands. J Cataract Refract Surg. 2019 Feb;45(2):146-152. doi: 10.1016/j.jcrs.2018.09.019. Epub 2018 Nov 22.

  PMID: 30471848 BACKGROUND

• Nichamin LD. Astigmatism management for modern phaco surgery. Int Ophthalmol Clin. 2003 Summer;43(3):53-63. doi: 10.1097/00004397-200343030-00006. No abstract available.

  PMID: 12881649 BACKGROUND

• Kessel L, Andresen J, Tendal B, Erngaard D, Flesner P, Hjortdal J. Toric Intraocular Lenses in the Correction of Astigmatism During Cataract Surgery: A Systematic Review and Meta-analysis. Ophthalmology. 2016 Feb;123(2):275-286. doi: 10.1016/j.ophtha.2015.10.002. Epub 2015 Nov 18.

  PMID: 26601819 BACKGROUND

MeSH Terms

Conditions

Cataract; Refractive Errors

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Björn Johansson, MD PhD FEBO

  Department of Biomedical and Clinical Sciences, Division of Sensory Organs and Communication, Medical Faculty of Linköping University, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Björn Johansson, MD PhD Phebo

CONTACT

+46 10 1031254; bjorn.johansson@regionostergotland.se

Helen Setterud, PhD, Assistant professor

CONTACT

+46 10 1038682; helen.setterud@regionostergotland.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All postoperative subjective data, for example visual acuity testing and subjective refraction, are collected by persons unaware of which group the examined persons belongs.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Senior consultant

Model Details: Comparison between two groups, one operated with standardized surgical incision and one with tailored surgical incisions

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 3, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 2028
• Access Criteria: Peer reviewers, interested colleagues and researchers