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

Primary Purpose

Cataract, Corneal Astigmatism

Status

Completed

Phase

Phase 4

Locations

Austria

Study Type

Interventional

Intervention

toric IOL

IOL combined with opposite clear corneal incision (OCCI)

About this trial

This is an interventional treatment trial for Cataract focused on measuring cataract surgery, astigmatism, opposite clear corneal incision, toric IOL, IOL rotational stability

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

toric IOL

IOL combined with opposite clear corneal incision (OCCI)

Arm Description

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

aspherical, acrylic IOL with OCCI

Outcomes

Primary Outcome Measures

Postoperative residual astigmatism

Secondary Outcome Measures

uncorrected distance visual acuity (UDVA)

Full Information

NCT ID

NCT01763151

First Posted

January 6, 2013

Last Updated

January 8, 2013

Sponsor

Vienna Institute for Research in Ocular Surgery

1. Study Identification

Unique Protocol Identification Number

NCT01763151

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vienna Institute for Research in Ocular Surgery

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract, Corneal Astigmatism

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

toric IOL

Arm Type

Active Comparator

Arm Description

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

Arm Title

IOL combined with opposite clear corneal incision (OCCI)

Arm Type

Active Comparator

Arm Description

aspherical, acrylic IOL with OCCI

Intervention Type

Device

Intervention Name(s)

toric IOL

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

IOL combined with opposite clear corneal incision (OCCI)

Intervention Description

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

Primary Outcome Measure Information:

Title

Postoperative residual astigmatism

Time Frame

9 months post-operatively

Secondary Outcome Measure Information:

Title

uncorrected distance visual acuity (UDVA)

Time Frame

9 months post-operatively

Other Pre-specified Outcome Measures:

Title

postoperative IOL rotation

Time Frame

3 months and 9 months post-operatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

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

City

Vienna

ZIP/Postal Code

1140

Country

Austria

12. IPD Sharing Statement

Learn more about this trial

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

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