Piggyback Sulcoflex Toric IOL for Correcting Refractive Error Following Corneal Transplantation

NCT ID: NCT01718184

Last Updated: 2012-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Refractive Error Corneal Implantation Intraocular Lens Implantation

Keywords

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sulcoflex toric corneal implantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sulcoflex

Sulcoflex intraocular lens implantation

Group Type EXPERIMENTAL

toric intraocular lens implantation

Intervention Type PROCEDURE

piggyback Sulcolflex toric intraocular lens implantation

Sulcoflex intraocular lens implantation

Intervention Type PROCEDURE

Interventions

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toric intraocular lens implantation

piggyback Sulcolflex toric intraocular lens implantation

Intervention Type PROCEDURE

Sulcoflex intraocular lens implantation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Einat Medical Inc.

INDUSTRY

Sponsor Role collaborator

Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Irit Bahar, MD

Role: PRINCIPAL_INVESTIGATOR

Rabim Medical Center, Israel

Locations

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Rabin Medical Center

Petah Tikva, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Irit Bahar, MD

Role: CONTACT

Phone: 972-3-9376101

Email: [email protected]

Alon Zahavi, MD

Role: CONTACT

Phone: 972-3-9376101

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 15093657 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18721724 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15093644 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8271176 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9530606 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9917781 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16412922 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11084268 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11860967 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17137990 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15474839 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17531710 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16246790 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10569176 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20610084 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21598871 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22055074 (View on PubMed)

Other Identifiers

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RabinMC Sulcoflex Toric IOL

Identifier Type: -

Identifier Source: org_study_id