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Comparison of Toric IOL Implantation and Opposite Clear Corneal Incision During Cataract Surgery to Correct Corneal Astigmatism

Comparison of Toric IOL Implantation and Opposite Clear Corneal Incision During Cataract Surgery to Correct Corneal Astigmatism

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01763151
Enrollment
55
Registered
2013-01-08
Start date
2010-09-30
Completion date
2012-12-31
Last updated
2013-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Corneal Astigmatism

Keywords

cataract surgery, astigmatism, opposite clear corneal incision, toric IOL, IOL rotational stability

Brief summary

With increasing demands of patients concerning refractive outcome after cataract surgery, toric intraocular lenses (IOLs) that correct corneal astigmatism have been introduced more widely to cataract surgery. Originally toric IOLs were used mainly for patients with high degrees of astigmatism, especially after corneal surgical procedures such as penetrating keratoplasty. Since a couple of years, toric IOLs are available from numerous manufacturers to correct lower amounts of astigmatism which are much more prevalent with about 30% having a corneal astigmatism of 0.75D or more in the cataract population. This should result in less spectacle dependence of patients due to the astigmatic correction. The alternative method to reduce corneal astigmatism as part of cataract surgery is to make incisions on the steeper axis of the cornea such as limbal relaxing incisions or an additional clear corneal incision opposite (OCCI) to the main cataract opening. These techniques are in use since more than 2 decades and are widely used in clinical routine. As with toric IOLs, precise alignment of the cuts with the axis of astigmatism is essential. The disadvantage of the incisional techniques is the variability of the effect between patients since it depends on factors such as the extent of scaring of the cuts after surgery as well as corneal thickness. The main advantage is the simplicity of the technique and the lower cost. Aim of this study is to compare toric IOL implantation and opposite clear corneal incision during cataract surgery to correct corneal astigmatism.

Interventions

DEVICEtoric IOL

implantation of an aspheric, toric, acrylic IOL during cataract surgery

PROCEDUREIOL combined with opposite clear corneal incision (OCCI)

aspherical, acrylic IOL with opposite clear corneal incision during cataract surgery

Sponsors

Vienna Institute for Research in Ocular Surgery
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Cataract * Age 21 and older * Regular corneal astigmatism 1.0 up to 2.5 D * written informed consent prior to surgery

Exclusion criteria

* Relevant other ophthalmic diseases such as: pseudoexfoliation, glaucoma, traumatic cataract corneal scars, and other co-morbidity that could affect capsule bag stability ( e.g. Marfan syndrome) * Irregular corneal astigmatism on corneal topography

Design outcomes

Primary

MeasureTime frame
Postoperative residual astigmatism9 months post-operatively

Secondary

MeasureTime frame
uncorrected distance visual acuity (UDVA)9 months post-operatively

Other

MeasureTime frame
postoperative IOL rotation3 months and 9 months post-operatively

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026