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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
ClinicalTrials.gov Identifier:
NCT01763151
First received: January 6, 2013
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Cataract
Corneal Astigmatism
Device: toric IOL
Procedure: IOL combined with opposite clear corneal incision (OCCI)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Toric IOL Implantation and Opposite Clear Corneal Incision During Cataract Surgery to Correct Corneal Astigmatism

Resource links provided by NLM:


Further study details as provided by Vienna Institute for Research in Ocular Surgery:

Primary Outcome Measures:
  • Postoperative residual astigmatism [ Time Frame: 9 months post-operatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • uncorrected distance visual acuity (UDVA) [ Time Frame: 9 months post-operatively ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • postoperative IOL rotation [ Time Frame: 3 months and 9 months post-operatively ] [ Designated as safety issue: Yes ]

Enrollment: 55
Study Start Date: September 2010
Study Completion Date: December 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: toric IOL
aspherical, toric acrylic IOL (Lentis L-312T, Oculentis, Germany)
Device: toric IOL
implantation of an aspheric, toric, acrylic IOL during cataract surgery
Active Comparator: IOL combined with opposite clear corneal incision (OCCI)
aspherical, acrylic IOL with OCCI
Procedure: IOL combined with opposite clear corneal incision (OCCI)
aspherical, acrylic IOL with opposite clear corneal incision during cataract surgery

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763151

Locations
Austria
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital
Vienna, Austria, 1140
Sponsors and Collaborators
Vienna Institute for Research in Ocular Surgery
  More Information

No publications provided

Responsible Party: Prim. Prof. Dr. Oliver Findl, MBA, MD, MBA, Vienna Institute for Research in Ocular Surgery
ClinicalTrials.gov Identifier: NCT01763151     History of Changes
Other Study ID Numbers: Viros_Askin
Study First Received: January 6, 2013
Last Updated: January 8, 2013
Health Authority: Austria: Federal Ministry for Health Family and Youth

Keywords provided by Vienna Institute for Research in Ocular Surgery:
cataract surgery, astigmatism, opposite clear corneal incision, toric IOL, IOL rotational stability

Additional relevant MeSH terms:
Cataract
Astigmatism
Lens Diseases
Eye Diseases
Refractive Errors

ClinicalTrials.gov processed this record on September 30, 2014