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

NCT ID: NCT01250964

Last Updated: 2010-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-11-30

Brief Summary

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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

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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

Conditions

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Cataracts Cataract Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Wound-assisted lens injection

Wound-assisted lens injection is considered neither superior or inferior to wound-directed lens injection.

Group Type ACTIVE_COMPARATOR

Lens insertion during cataract surgery

Intervention Type PROCEDURE

After cataract removal during cataract surgery, a lens needs to be injected into the eye. Both arms are routinely used but different methods for injecting the lens.

Wound-directed lens injection

Wound-directed lens injection is neither considered superior nor inferior to wound-assisted lens injection.

Group Type ACTIVE_COMPARATOR

Lens insertion during cataract surgery

Intervention Type PROCEDURE

After cataract removal during cataract surgery, a lens needs to be injected into the eye. Both arms are routinely used but different methods for injecting the lens.

Interventions

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Lens insertion during cataract surgery

After cataract removal during cataract surgery, a lens needs to be injected into the eye. Both arms are routinely used but different methods for injecting the lens.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Dept. of Ophthalmology, UNC Chapel Hill

Principal Investigators

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Kenneth Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

UNC dept. of ophthalmology

Locations

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Kittner Eye Center

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

References

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Tsuneoka H, Hayama A, Takahama M. Ultrasmall-incision bimanual phacoemulsification and AcrySof SA30AL implantation through a 2.2 mm incision. J Cataract Refract Surg. 2003 Jun;29(6):1070-6. doi: 10.1016/s0886-3350(03)00076-2.

Reference Type BACKGROUND
PMID: 12842669 (View on PubMed)

Kamae KK, Werner L, Chang W, Johnson JT, Mamalis N. Intraocular pressure changes during injection of microincision and conventional intraocular lenses through incisions smaller than 3.0 mm. J Cataract Refract Surg. 2009 Aug;35(8):1430-6. doi: 10.1016/j.jcrs.2009.03.038.

Reference Type BACKGROUND
PMID: 19631132 (View on PubMed)

Osher RH. Microcoaxial phacoemulsification Part 2: clinical study. J Cataract Refract Surg. 2007 Mar;33(3):408-12. doi: 10.1016/j.jcrs.2006.10.055.

Reference Type BACKGROUND
PMID: 17321390 (View on PubMed)

Kohnen T, Klaproth OK. Incision sizes before and after implantation of SN60WF intraocular lenses using the Monarch injector system with C and D cartridges. J Cataract Refract Surg. 2008 Oct;34(10):1748-53. doi: 10.1016/j.jcrs.2008.06.031.

Reference Type BACKGROUND
PMID: 18812128 (View on PubMed)

Ventura AC, Walti R, Bohnke M. Corneal thickness and endothelial density before and after cataract surgery. Br J Ophthalmol. 2001 Jan;85(1):18-20. doi: 10.1136/bjo.85.1.18.

Reference Type BACKGROUND
PMID: 11133705 (View on PubMed)

Masket S, Wang L, Belani S. Induced astigmatism with 2.2- and 3.0-mm coaxial phacoemulsification incisions. J Refract Surg. 2009 Jan;25(1):21-4. doi: 10.3928/1081597X-20090101-04.

Reference Type BACKGROUND
PMID: 19244949 (View on PubMed)

Other Identifiers

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10-0435

Identifier Type: -

Identifier Source: org_study_id