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Clinical Trials/NCT01763151
NCT01763151
Completed
Phase 4

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

Vienna Institute for Research in Ocular Surgery1 site in 1 country55 target enrollmentSeptember 2010

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Cataract
Sponsor
Vienna Institute for Research in Ocular Surgery
Enrollment
55
Locations
1
Primary Endpoint
Postoperative residual astigmatism
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
December 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Vienna Institute for Research in Ocular Surgery
Responsible Party
Principal Investigator
Principal Investigator

Prim. Prof. Dr. Oliver Findl, MBA

MD, MBA

Vienna Institute for Research in Ocular Surgery

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Postoperative residual astigmatism

Time Frame: 9 months post-operatively

Secondary Outcomes

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

Study Sites (1)

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