Refractive ErrorNCT01718184
Piggyback Sulcoflex Toric IOL for Correcting Refractive Error Following Corneal Transplantation
A study testing toric intraocular lens implantation and Sulcoflex intraocular lens implantation in people with Refractive Error and Corneal Implantation, run by Rabin Medical Center at 1 site in Israel.
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractive Error, Corneal Implantation, Intraocular Lens Implantation
- What is being tested?
- toric intraocular lens implantation and Sulcoflex intraocular lens implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2012to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- after corneal transplantation with refractive errors
- after cataract removal and intraocular lens implantation
Who cannot join
- other ophthalmologic disorders limiting vision including glaucoma, AMD, profound amblyopia
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center
Petah Tikva
Irit Bahar, MD
About this study
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
- Being tested
- toric intraocular lens implantation, Sulcoflex intraocular lens implantation
- Keywords
- sulcoflex, toric, corneal implantation
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
toric intraocular lens implantationProcedure or surgery
piggyback Sulcolflex toric intraocular lens implantation
Sulcoflex intraocular lens implantationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Sulcoflex | Experimental | Sulcoflex intraocular lens implantation Receives: Procedure: toric intraocular lens implantation; Procedure: Sulcoflex intraocular lens implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected and uncorrected visual acuity
Best corrected and uncorrected visual acuity following the IOL implantation
Measured: 3 month
Secondary outcomes (1)
Ocular complications
pigmentary dispersion, iris bulging, inter lenticular opacifications, lens decentration
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionApr 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Refractive ErrorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Einat Medical Inc.
- Responsible party
- Sponsor
- Investigators
- Irit Bahar, MD, Principal investigator, Rabim Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718184
- Sponsor's protocol ID
- RabinMC Sulcoflex Toric IOL
- Status last verified
- Jul 2012
- First submitted
- 29 Oct 2012
- Last updated
- 31 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15093657Mamalis 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.
PubMed 18721724Paul 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.
PubMed 15093644Gayton 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.
PubMed 8271176Gayton 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.
PubMed 9530606Gayton 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.
PubMed 9917781Habot-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.
PubMed 16412922Werner 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.
PubMed 11084268Werner 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.
PubMed 11860967Baumeister 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.
PubMed 17137990Chang 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.
PubMed 15474839Chang 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.
PubMed 17531710Iwase 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.
PubMed 16246790Durak 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.
PubMed 10569176Kahraman 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.
PubMed 20610084
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piggyback Sulcoflex Toric IOL for Correcting Refractive Error Following Corneal Transplantation
- ClinicalTrials.gov ID
- NCT01718184
- Acronym / sponsor ID
- RabinMC Sulcoflex Toric IOL
- Keywords
- sulcoflex, toric, corneal implantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Einat Medical Inc.
- Study start
- Oct 2012
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 31 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sulcoflex | Experimental | Procedure: toric intraocular lens implantation, Procedure: Sulcoflex intraocular lens implantationSulcoflex intraocular lens implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- after corneal transplantation with refractive errors
- after cataract removal and intraocular lens implantation
Key exclusion criteria (1 listed)
- other ophthalmologic disorders limiting vision including glaucoma, AMD, profound amblyopia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| toric intraocular lens implantationpiggyback Sulcolflex toric intraocular lens implantation | Procedure or surgery | Sulcoflex |
| Sulcoflex intraocular lens implantation | Procedure or surgery | Sulcoflex |
Primary outcome
Best corrected and uncorrected visual acuity
Time frame: 3 month
Best corrected and uncorrected visual acuity following the IOL implantation
1 secondary outcome
Ocular complications
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2012.
- Background: PubMed 15093657Leaming 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.
- Background: PubMed 18721724Mamalis 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.
- Background: PubMed 15093644Paul 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.
- Background: PubMed 8271176Gayton 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.
- Background: PubMed 9530606Gayton 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.
- Background: PubMed 9917781Gayton 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.
- Background: PubMed 16412922Habot-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.
- Background: PubMed 11084268Werner 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.
- Background: PubMed 11860967Werner 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.
- Background: PubMed 17137990Baumeister 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.
- Background: PubMed 15474839Chang 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.
- Background: PubMed 17531710Chang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irit Bahar, MD principal investigator
Rabim Medical Center, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing toric intraocular lens implantation and Sulcoflex intraocular lens implantation in people with Refractive Error and Corneal Implantation, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irit Bahar, MD (972-3-9376101, iritbahar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best corrected and uncorrected visual acuity (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01718184, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2012.