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

NCT01763151 | Completed Phase 4

• 1 other identifier: Viros_Askin
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; Corneal Astigmatism

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Postoperative residual astigmatism

  9 months post-operatively

Secondary Outcomes (1)

• uncorrected distance visual acuity (UDVA)

  9 months post-operatively

Other Outcomes (1)

• postoperative IOL rotation

  3 months and 9 months post-operatively

Study Arms (2)

toric IOL

ACTIVE COMPARATOR

aspherical, toric acrylic IOL (Lentis L-312T, Oculentis, Germany)

Device: toric IOL

IOL combined with opposite clear corneal incision (OCCI)

ACTIVE COMPARATOR

aspherical, acrylic IOL with OCCI

Procedure: IOL combined with opposite clear corneal incision (OCCI)

Interventions

toric IOL DEVICE

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

toric IOL

IOL combined with opposite clear corneal incision (OCCI) PROCEDURE

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

IOL combined with opposite clear corneal incision (OCCI)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vienna Institute for Research in Ocular Surgery: lead

Study Sites (1)

Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital

Vienna, 1140, Austria

Location

MeSH Terms

Conditions

Cataract; Astigmatism

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MBA

Study Record Dates

• First Submitted: January 6, 2013
• First Posted: January 8, 2013
• Study Start: September 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 10, 2013

Record last verified: 2013-01

Locations

AU (1)