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

Not Applicable

Completed

• Conditions: Cataracts; Cataract Surgery
• Interventions: Procedure: Lens insertion during cataract surgery

• Registration Number: NCT01250964
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief 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.

Detailed 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 Timeline

• Study Start: 2010-04
• Status Verified: 2010-11
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Study First Submitted: 2010-11-29
• Study First Submitted QC: 2010-11-30
• Last Update Submitted: 2010-11-30
• Study First Posted: 2010-12-01
• Last Update Posted: 2010-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Eligible patients include those who undergo uncomplicated cataract extraction surgery and IOL implantation by KLC.

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Exclusion Criteria

Patients who:

1. suffer from diabetes and have more than mild background diabetic retinopathy,
2. have a history of intraocular surgery,
3. have a history of ocular trauma,
4. have known pathology of the cornea,
5. have a history of intraocular inflammation,
6. are unable to understand English,
7. are decisionally impaired,
8. are currently incarcerated, or
9. are less than 18 years of age.

No exclusions will be made on the basis of gender, ethnicity, or race.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wound-assisted lens injection	Lens insertion during cataract surgery	Wound-assisted lens injection is considered neither superior or inferior to wound-directed lens injection.
Wound-directed lens injection	Lens insertion during cataract surgery	Wound-directed lens injection is neither considered superior nor inferior to wound-assisted lens injection.

Primary Outcome Measures

Name	Time	Method
Surgically induced astigmatism	1 month	measured by topography at 1 month post operative visit

Secondary Outcome Measures

Name	Time	Method
Endothelial cell loss	one month	As measured by specular microscopy
Best corrected visual acuity	one month	By manifest refraction
Final incision size	intraoperatively (day #0)	measured with incision gauges before and after lens injection.

Trial Locations

Locations (1)

Kittner Eye Center; 🇺🇸 Chapel Hill, North Carolina, United States