NCT01250964

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2010

Completed
Last Updated

December 1, 2010

Status Verified

November 1, 2010

Enrollment Period

7 months

First QC Date

November 29, 2010

Last Update Submit

November 30, 2010

Conditions

CataractsCataract Surgery

Outcome Measures

Primary Outcomes (1)

  • Surgically induced astigmatism

    measured by topography at 1 month post operative visit

    1 month

Secondary Outcomes (3)

  • Endothelial cell loss

    one month

  • Best corrected visual acuity

    one month

  • Final incision size

    intraoperatively (day #0)

Study Arms (2)

Wound-assisted lens injection

ACTIVE COMPARATOR

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

Procedure: Lens insertion during cataract surgery

Wound-directed lens injection

ACTIVE COMPARATOR

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

Procedure: Lens insertion during cataract surgery

Interventions

Lens insertion during cataract surgeryPROCEDURE

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-assisted lens injectionWound-directed lens injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • suffer from diabetes and have more than mild background diabetic retinopathy,
  • have a history of intraocular surgery,
  • have a history of ocular trauma,
  • have known pathology of the cornea,
  • have a history of intraocular inflammation,
  • are unable to understand English,
  • are decisionally impaired,
  • are currently incarcerated, or
  • are less than 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kittner Eye Center

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (6)

  • 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.

    PMID: 12842669BACKGROUND

  • 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.

    PMID: 19631132BACKGROUND

  • 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.

    PMID: 17321390BACKGROUND

  • 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.

    PMID: 18812128BACKGROUND

  • 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.

    PMID: 11133705BACKGROUND

  • 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.

    PMID: 19244949BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Kenneth Cohen, MD

    UNC dept. of ophthalmology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 29, 2010

First Posted

December 1, 2010

Study Start

April 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

December 1, 2010

Record last verified: 2010-11

Locations

US(1)