A Phase 4 interventional study of toric IOL and IOL combined with opposite clear corneal incision (OCCI) in Cataract and Corneal Astigmatism, sponsored by Vienna Institute for Research in Ocular Surgery. Completed at 1 site in Austria. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2013-01-10.
Sponsored by Vienna Institute for Research in Ocular Surgery · Phase 4, Interventional, and Treatment
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.
1,726 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 55 is below the median of 80 across 1,171 interventional studies indexed under Cataract.
Browse Cataract studies →Vienna Institute for Research in Ocular Surgery is the lead sponsor of 65 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
aspherical, toric acrylic IOL (Lentis L-312T, Oculentis, Germany)
Device: toric IOL
aspherical, acrylic IOL with OCCI
Procedure: IOL combined with opposite clear corneal incision (OCCI)
implantation of an aspheric, toric, acrylic IOL during cataract surgery
aspherical, acrylic IOL with opposite clear corneal incision during cataract surgery
Postoperative residual astigmatism
Time frame: 9 months post-operatively
uncorrected distance visual acuity (UDVA)
Time frame: 9 months post-operatively
postoperative IOL rotation
Time frame: 3 months and 9 months post-operatively
The record gives a start of Sep 2010, a primary completion of Aug 2012 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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Vienna Institute for Research in Ocular Surgery