Piggyback Sulcoflex Toric IOL for Correcting Refractive Error Following Corneal Transplantation - Full Text View

Purpose

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

Condition	Intervention
Refractive Error Corneal Implantation Intraocular Lens Implantation	Procedure: toric intraocular lens implantation Procedure: Sulcoflex intraocular lens implantation

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Refractive Errors

U.S. FDA Resources

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:

Best corrected and uncorrected visual acuity [ Time Frame: 3 month ] [ Designated as safety issue: No ]
Best corrected and uncorrected visual acuity following the IOL implantation

Secondary Outcome Measures:

Ocular complications [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
pigmentary dispersion, iris bulging, inter lenticular opacifications, lens decentration

Other Outcome Measures:

Refractive outcomes [ Time Frame: 3 months ] [ Designated as safety issue: No ]
refractive outcomes following surgical intervention

Estimated Enrollment:	25
Study Start Date:	October 2012
Estimated Study Completion Date:	October 2014
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Sulcoflex Sulcoflex intraocular lens implantation	Procedure: toric intraocular lens implantation piggyback Sulcolflex toric intraocular lens implantation Procedure: Sulcoflex intraocular lens implantation

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01718184

Contacts

Contact: Irit Bahar, MD	972-3-9376101	iritbahar@gmail.com
Contact: Alon Zahavi, MD	972-3-9376101	alonzahavi@gmail.com

Locations

Israel
Rabin Medical Center	Recruiting
Petah Tiqwa, Israel
Principal Investigator: Irit Bahar, MD

Sponsors and Collaborators

Rabin Medical Center

Einat Medical INC

Investigators

Principal Investigator:

Irit Bahar, MD

Rabim Medical Center, Israel

More Information

Publications:

Leaming DV. Practice styles and preferences of ASCRS members--2003 survey. J Cataract Refract Surg. 2004 Apr;30(4):892-900.

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.

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.

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.

Gayton JL. Secondary implantation of a double intraocular lens after penetrating keratoplasty. J Cataract Refract Surg. 1998 Feb;24(2):281-2.

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.

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.

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.

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.

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.

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

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.

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

Durak I, Ferliel ST, Söylev M, Saatçi O. Pre-Descemet's membrane hemorrhage after secondary intraocular lens implantation. J Cataract Refract Surg. 1999 Nov;25(11):1554-6.

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

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.

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. Epub 2011 Nov 4.

Responsible Party:	Rabin Medical Center
ClinicalTrials.gov Identifier:	NCT01718184 History of Changes
Other Study ID Numbers:	RabinMC Sulcoflex Toric IOL
Study First Received:	October 29, 2012
Last Updated:	October 29, 2012
Health Authority:	Israel: Rabin Medical Center

Keywords provided by Rabin Medical Center:

sulcoflex
toric
corneal implantation

Additional relevant MeSH terms:

Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013