Piggyback Sulcoflex Toric IOL for Correcting Refractive Error Following Corneal Transplantation
Sponsor
Rabin Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT01718184
Collaborator
Einat Medical Inc. (Industry)
25
1
1
24
1
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date
:
Oct 1, 2012
Anticipated Primary Completion Date
:
Apr 1, 2014
Anticipated Study Completion Date
:
Oct 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sulcoflex Sulcoflex intraocular lens implantation |
Procedure: toric intraocular lens implantation
piggyback Sulcolflex toric intraocular lens implantation
Procedure: Sulcoflex intraocular lens implantation
|
Outcome Measures
Primary Outcome Measures
- Best corrected and uncorrected visual acuity [3 month]
Best corrected and uncorrected visual acuity following the IOL implantation
Secondary Outcome Measures
- Ocular complications [3 months]
pigmentary dispersion, iris bulging, inter lenticular opacifications, lens decentration
Other Outcome Measures
- Refractive outcomes [3 months]
refractive outcomes following surgical intervention
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rabin Medical Center | Petah Tiqwa | Israel |
Sponsors and Collaborators
- Rabin Medical Center
- Einat Medical Inc.
Investigators
- Principal Investigator: Irit Bahar, MD, Rabim Medical Center, Israel
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- Iwase T, Tanaka N. Elevated intraocular pressure in secondary piggyback intraocular lens implantation. J Cataract Refract Surg. 2005 Sep;31(9):1821-3.
- 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.
- 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.
- 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. doi: 10.1016/j.jcrs.2008.05.046.
- 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.
- 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.
- 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.
- 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.
Responsible Party:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01718184
Other Study ID Numbers:
- RabinMC Sulcoflex Toric IOL
First Posted:
Oct 31, 2012
Last Update Posted:
Oct 31, 2012
Last Verified:
Jul 1, 2012
Keywords provided by Rabin Medical Center
Additional relevant MeSH terms: