Refractive Error Clinical Trial
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
Status | Recruiting |
Enrollment | 25 |
Est. completion date | October 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Rabin Medical Center | Petah Tiqwa |
Lead Sponsor | Collaborator |
---|---|
Rabin Medical Center | Einat Medical Inc. |
Israel,
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. — View Citation
Chang SH, Lim G. Secondary pigmentary glaucoma associated with piggyback intraocular lens implantation. J Cataract Refract Surg. 2004 Oct;30(10):2219-22. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Gayton JL. Secondary implantation of a double intraocular lens after penetrating keratoplasty. J Cataract Refract Surg. 1998 Feb;24(2):281-2. — View Citation
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. — View Citation
Iwase T, Tanaka N. Elevated intraocular pressure in secondary piggyback intraocular lens implantation. J Cataract Refract Surg. 2005 Sep;31(9):1821-3. — View Citation
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. — View Citation
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. — View Citation
Leaming DV. Practice styles and preferences of ASCRS members--2003 survey. J Cataract Refract Surg. 2004 Apr;30(4):892-900. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Refractive outcomes | refractive outcomes following surgical intervention | 3 months | No |
Primary | Best corrected and uncorrected visual acuity | Best corrected and uncorrected visual acuity following the IOL implantation | 3 month | No |
Secondary | Ocular complications | pigmentary dispersion, iris bulging, inter lenticular opacifications, lens decentration | 3 months | Yes |
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