NCT01718184

Brief Summary

A prospective study to evaluate the safety and efficacy of a piggyback sulcoflex toric intraocular lens in pseudophakic patients for correcting refractive errors following corneal transplantation

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2012

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 31, 2012

Status Verified

July 1, 2012

Enrollment Period

1.5 years

First QC Date

October 29, 2012

Last Update Submit

October 29, 2012

Conditions

Refractive ErrorCorneal ImplantationIntraocular Lens Implantation

Keywords

sulcoflextoriccorneal implantation

Outcome Measures

Primary Outcomes (1)

  • Best corrected and uncorrected visual acuity

    Best corrected and uncorrected visual acuity following the IOL implantation

    3 month

Secondary Outcomes (1)

  • Ocular complications

    3 months

Other Outcomes (1)

  • Refractive outcomes

    3 months

Study Arms (1)

Sulcoflex

EXPERIMENTAL

Sulcoflex intraocular lens implantation

Procedure: toric intraocular lens implantationProcedure: Sulcoflex intraocular lens implantation

Interventions

toric intraocular lens implantationPROCEDURE

piggyback Sulcolflex toric intraocular lens implantation

Sulcoflex
Sulcoflex intraocular lens implantationPROCEDURE
Sulcoflex

Eligibility Criteria

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

You may qualify if:

  • after corneal transplantation with refractive errors
  • after cataract removal and intraocular lens implantation

You may not qualify if:

  • other ophthalmologic disorders limiting vision including glaucoma, AMD, profound amblyopia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center

Petah Tikva, Israel

RECRUITING

Related Publications (17)

  • Leaming DV. Practice styles and preferences of ASCRS members--2003 survey. J Cataract Refract Surg. 2004 Apr;30(4):892-900. doi: 10.1016/j.jcrs.2004.02.064.

    PMID: 15093657BACKGROUND

  • Mamalis N, Brubaker J, Davis D, Espandar L, Werner L. Complications of foldable intraocular lenses requiring explantation or secondary intervention--2007 survey update. J Cataract Refract Surg. 2008 Sep;34(9):1584-91. doi: 10.1016/j.jcrs.2008.05.046.

    PMID: 18721724BACKGROUND

  • Paul RA, Chew HF, Singal N, Rootman DS, Slomovic AR. Piggyback intraocular lens implantation to correct myopic pseudophakic refractive error after penetrating keratoplasty. J Cataract Refract Surg. 2004 Apr;30(4):821-5. doi: 10.1016/j.jcrs.2003.08.008.

    PMID: 15093644BACKGROUND

  • Gayton JL, Sanders VN. Implanting two posterior chamber intraocular lenses in a case of microphthalmos. J Cataract Refract Surg. 1993 Nov;19(6):776-7. doi: 10.1016/s0886-3350(13)80349-5.

    PMID: 8271176BACKGROUND

  • Gayton JL. Secondary implantation of a double intraocular lens after penetrating keratoplasty. J Cataract Refract Surg. 1998 Feb;24(2):281-2. doi: 10.1016/s0886-3350(98)80212-5.

    PMID: 9530606BACKGROUND

  • Gayton JL, Sanders V, Van der Karr M, Raanan MG. Piggybacking intraocular implants to correct pseudophakic refractive error. Ophthalmology. 1999 Jan;106(1):56-9. doi: 10.1016/S0161-6420(99)90005-2.

    PMID: 9917781BACKGROUND

  • Habot-Wilner Z, Sachs D, Cahane M, Alhalel A, Desatnik H, Schwalb E, Barequet IS. Refractive results with secondary piggyback implantation to correct pseudophakic refractive errors. J Cataract Refract Surg. 2005 Nov;31(11):2101-3. doi: 10.1016/j.jcrs.2005.05.023.

    PMID: 16412922BACKGROUND

  • Werner L, Shugar JK, Apple DJ, Pandey SK, Escobar-Gomez M, Visessook N, Evans BB. Opacification of piggyback IOLs associated with an amorphous material attached to interlenticular surfaces. J Cataract Refract Surg. 2000 Nov;26(11):1612-9. doi: 10.1016/s0886-3350(00)00485-5.

    PMID: 11084268BACKGROUND

  • Werner L, Apple DJ, Pandey SK, Solomon KD, Snyder ME, Brint SF, Gayton JL, Shugar JK, Trivedi RH, Izak AM. Analysis of elements of interlenticular opacification. Am J Ophthalmol. 2002 Mar;133(3):320-6. doi: 10.1016/s0002-9394(01)01405-2.

    PMID: 11860967BACKGROUND

  • Baumeister M, Kohnen T. Scheimpflug measurement of intraocular lens position after piggyback implantation of foldable intraocular lenses in eyes with high hyperopia. J Cataract Refract Surg. 2006 Dec;32(12):2098-104. doi: 10.1016/j.jcrs.2006.08.033.

    PMID: 17137990BACKGROUND

  • Chang SH, Lim G. Secondary pigmentary glaucoma associated with piggyback intraocular lens implantation. J Cataract Refract Surg. 2004 Oct;30(10):2219-22. doi: 10.1016/j.jcrs.2004.03.034.

    PMID: 15474839BACKGROUND

  • Chang WH, Werner L, Fry LL, Johnson JT, Kamae K, Mamalis N. Pigmentary dispersion syndrome with a secondary piggyback 3-piece hydrophobic acrylic lens. Case report with clinicopathological correlation. J Cataract Refract Surg. 2007 Jun;33(6):1106-9. doi: 10.1016/j.jcrs.2007.01.044.

    PMID: 17531710BACKGROUND

  • Iwase T, Tanaka N. Elevated intraocular pressure in secondary piggyback intraocular lens implantation. J Cataract Refract Surg. 2005 Sep;31(9):1821-3. doi: 10.1016/j.jcrs.2005.06.034.

    PMID: 16246790BACKGROUND

  • Durak I, Ferliel ST, Soylev M, Saatci O. Pre-Descemet's membrane hemorrhage after secondary intraocular lens implantation. J Cataract Refract Surg. 1999 Nov;25(11):1554-6. doi: 10.1016/s0886-3350(99)00249-7.

    PMID: 10569176BACKGROUND

  • Kahraman G, Amon M. New supplementary intraocular lens for refractive enhancement in pseudophakic patients. J Cataract Refract Surg. 2010 Jul;36(7):1090-4. doi: 10.1016/j.jcrs.2009.12.045.

    PMID: 20610084BACKGROUND

  • Khan MI, Muhtaseb M. Performance of the Sulcoflex piggyback intraocular lens in pseudophakic patients. J Refract Surg. 2011 Sep;27(9):693-6. doi: 10.3928/1081597X-20110512-01. Epub 2011 May 20.

    PMID: 21598871BACKGROUND

  • McIntyre JS, Werner L, Fuller SR, Kavoussi SC, Hill M, Mamalis N. Assessment of a single-piece hydrophilic acrylic IOL for piggyback sulcus fixation in pseudophakic cadaver eyes. J Cataract Refract Surg. 2012 Jan;38(1):155-62. doi: 10.1016/j.jcrs.2011.06.035. Epub 2011 Nov 4.

    PMID: 22055074BACKGROUND

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Irit Bahar, MD

    Rabim Medical Center, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Irit Bahar, MD

CONTACT

972-3-9376101iritbahar@gmail.com

Alon Zahavi, MD

CONTACT

972-3-9376101alonzahavi@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2012

First Posted

October 31, 2012

Study Start

October 1, 2012

Primary Completion

April 1, 2014

Study Completion

October 1, 2014

Last Updated

October 31, 2012

Record last verified: 2012-07

Locations

IL(1)