Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01718184
Other study ID # RabinMC Sulcoflex Toric IOL
Secondary ID
Status Recruiting
Phase N/A
First received October 29, 2012
Last updated October 29, 2012
Start date October 2012
Est. completion date October 2014

Study information

Verified date July 2012
Source Rabin Medical Center
Contact Irit Bahar, MD
Phone 972-3-9376101
Email iritbahar@gmail.com
Is FDA regulated No
Health authority Israel: Rabin Medical Center
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

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

Study Design

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


Intervention

Procedure:
toric intraocular lens implantation
piggyback Sulcolflex toric intraocular lens implantation
Sulcoflex intraocular lens implantation


Locations

Country Name City State
Israel Rabin Medical Center Petah Tiqwa

Sponsors (2)

Lead Sponsor Collaborator
Rabin Medical Center Einat Medical Inc.

Country where clinical trial is conducted

Israel, 

References & Publications (17)

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 allClick here to view all references

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT04075591 - Wavefront-guided LASIK for Monovision Treatment of Myopic Subjects With Presbyopia N/A
Completed NCT03169153 - Clinical Comparison of Silicone Hydrogel Monthly Lenses N/A
Completed NCT02517567 - DAILIES TOTAL1® - Comparative Assessment of Tear Film Evaporation N/A
Recruiting NCT02844556 - International Multicenter Study on SMILE Surgery N/A
Completed NCT02235831 - DAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance N/A
Completed NCT02214797 - Dispensing Study to Assess Visual Performance of Prototype Contact Lenses N/A
Completed NCT01941498 - WaveLight® Refractive Myopic Study N/A
Completed NCT01917162 - Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses (Study 2) N/A
Completed NCT01629706 - Determination of Cell Population in Solution-Induced Corneal Staining (SICS) and Symptomatic Versus Asymptomatic Lens Wearers N/A
Completed NCT01440322 - AIR OPTIX® COLORS Registration Trial N/A
Completed NCT01233089 - Fitting Children With Contact Lenses N/A
Completed NCT01211535 - Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers N/A
Completed NCT01163760 - Clinical Evaluation of Two Daily Disposable Contact Lenses N/A
Completed NCT02484586 - Dispensing Study to Assess the Visual Performance of Optimised Prototype Contact Lenses N/A
Completed NCT02252133 - DAILIES TOTAL1® Lens Centration in a Japanese Population N/A
Completed NCT01941485 - WaveLight® Refractive Flap Accuracy Study N/A
Completed NCT02103309 - Comparative Evaluation of Contact Lens Centering of DAILIES® AquaComfort Plus® Versus 1-DAY ACUVUE® MOIST® in Japan N/A
Completed NCT01951573 - Evaluation of a New Daily Disposable Multifocal Contact Lens Design N/A
Completed NCT01997216 - Multifocal Lens Design Evaluation N/A
Completed NCT01220466 - Performance and Acceptability of iDesign N/A