Endothelial Cell Loss and Induced Astigmatism After Wound-directed and Wound-assisted IOL Injection

Cataracts Clinical Trial

Official title: Endothelial Cell Loss and Surgically Induced Astigmatism After 2.2 mm Wound Assisted vs 2.4 mm Wound-Directed Clear Corneal Incisions for Intraocular Lens Insertion During Cataract Surgery

Status Completed

Clinical Trial Summary

The purpose of this study is to determine if there is any difference in astigmatism (eye surface curvature) or corneal endothelial cell density (the inner cell lining of the eye surface) after two different methods for inserting a lens during cataract surgery.

Clinical Trial Description

Cataract surgery (removal of a cloudy lens) is currently performed through increasingly smaller incisions. Bimanual surgery, where two instruments are used to remove the lens, is performed through two 1.4 mm incisions. Typically, one of these incisions is enlarged to 2.2 or 2.4 mm in order that the IOL (artificial lens) can be inserted into the eye. Surgeons insert these lenses by placing a lens injector cartridge completely into the eye (wound-directed insertion) or by placing only the tip inside the incision (wound-assisted insertion). While wound-assisted insertion can be performed through slightly smaller incisions (2.2 mm versus 2.4 mm for wound-directed insertion), both methods of insertion cause some incision enlargement. There is some evidence that wound-assisted insertion can cause very short-term pressure within the eye to go up. Neither method is considered inferior or superior to the other, and the primary investigator (Dr. Kenneth Cohen) routinely uses both methods.

No studies have directly compared wound-healing characteristics between these two methods. We seek to compare differences in:

1. Surgically-induced astigmatism (changes in the corneal curvature from cataract surgery incisions.

2. Endothelial cell density loss. Endothelial cells line the inside surface of the cornea, and their overall density can be decreased by cataract surgery.

3. Best-corrected vision after surgery

4. Sizes of the incisions after lens injection ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astigmatism
• Cataract
• Cataract Surgery
• Cataracts

• NCT number: NCT01250964
• Study type: Interventional
• Source: University of North Carolina, Chapel Hill
• Status: Completed
• Phase: N/A
• Start date: April 2010
• Completion date: November 2010