AstigmatismT-IOLNCT02412215
Rotational Stability After Nanoflex Collamer Toric Intraocular Lens Implantation in Astigmatic Patients
A study testing Phacoemulsification with toric Nanoflex IOL implantation and NanoFlex toric Intraocular Lens in people with Astigmatism, run by University of Turin, Italy at 1 site in Italy.
Trial summary
This study aims to assess the rotational stability of the new collameric Nanoflex toric intraocular lens (T-IOL) by STAAR inserted in astigmatic patients after cataract surgery. The purpose of this study is also to determine whether the use of a toric intraocular lens (T-IOL) improves visual acuity. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Astigmatism
- What is being tested?
- Phacoemulsification with toric Nanoflex IOL implantation and NanoFlex toric Intraocular Lens
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2015to Sep 2017
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of 60 years of age ore more
- Cataract
- Corneal astigmatism of 1 diopter (D) or more
Who cannot join
- Primary or secondary pathological conditions of the cornea
- Zonular fibres pathologies (phacodonesis, pseudoexfoliation syndrome)
- Irregular astigmatism (corneal scar, keratoconus, pterygium)
- Traumatic cataract
- Previous ocular surgery
- Complications during cataract surgery
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ophthalmology Institute, University of Turin
Turin, 10138
Antonio M Fea, MD, PhD, +39 011 566 6039, antoniomfea@gmail.com
About this study
Official title: Rotational Stability After Nanoflex Collamer Toric Intraocular Lens Implantation in Astigmatic Patients Undergoing Cataract Surgery
This study aims to assess the rotational stability of the new collameric Nanoflex toric intraocular lens (T-IOL) by STAAR inserted in astigmatic patients after cataract surgery.
The purpose of this study is also to determine whether the use of a toric intraocular lens (T-IOL) improves visual acuity.
Read the detailed description
A good rotational stability of toric intraocular lenses (T-IOL) allows an accurate refractive correction. However, many aspects -both pre-operative and post-operative- can interfere causing T-IOL rotation and misalignment.
Complete preoperative ocular evaluation is performed including slit-lamp examination, uncorrected distance visual acuity (UDVA), best-corrected visual acuity (BCVA), Javal keratometry, corneal Scheimplug tomography (Pentacam), optical biometry (IOL Master), Goldman applanation tonometry and fundus evaluation through dilated pupils. The spherical IOL power is calculated considering the axial length obtained with optical biometry, the magnitude of astigmatism derived from Javal keratometry and the steepest axis obtained with corneal tomography. The power of the toric IOL is determined with the online Staar Toric IOL calculator. The reference landmarks are also marked preoperatively with a sterile methylene blue fine point pen. The marking is rechecked in the operating theatre with the electronic toric marker ASICO.
Postoperative evaluation for IOL alignment and rotational stability is performed with slit-lamp photography on dilated pupils. Images are captured with Haag Streit slit lamp BQ 900 and are evaluated with the image-analysis software Protractor (Staar).
- Conditions
- Astigmatism
- Being tested
- Phacoemulsification with toric Nanoflex IOL implantation, NanoFlex toric Intraocular Lens
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phacoemulsification with toric Nanoflex IOL implantationProcedure or surgery
A self-sealing incision is made with a 2.2mm knife at 110°. Phacoemulsification is performed. The foldable nanoFlex toric IOL is injected in the capsular bag using the nanoPoint single-use injector system (STAAR) or 1620 sofTip Injector (ASICO). The IOL is rotated to align the cylinder axis with the steep corneal meridian using Z align function by Callisto Eye. Every movement of the IOL axis marks are noted.
NanoFlex toric Intraocular LensDevice
| Study group | Role | What they receive |
|---|---|---|
| Toric Nanoflex IOL | Experimental | Phacoemulsification with toric Nanoflex IOL implantation Receives: Procedure: Phacoemulsification with toric Nanoflex IOL implantation; Device: NanoFlex toric Intraocular Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in rotational stability of the toric intraocular lens (T-IOL).
The misalignment of the lens is defined as the difference (Δ) between the intended axis and the actual axis of the new collameric Nanoflex T-IOL by STAAR.
Measured: Change of rotational stability at 1 day, 1 week, 1 month, 3 months, 6 months, 12 months and 18 months after surgery.
Secondary outcomes (1)
Correction of the astigmatism.
Effective correction evaluated through corrected distance visual acuity (CDVA) and uncorrected distance visual acuity (UDVA).
Measured: Change in visual acuity at 1 day, 1 week, 1 month, 3 months, 6 months, 12 months and 18 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for AstigmatismStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Fea, University of Turin, Italy
- Investigators
- Antonio M Fea, MD, PhD, Principal investigator, Department of Surgical Sciences, Ophthalmology Institute, University of Turin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412215
- Sponsor's protocol ID
- 0026769
- Acronym
- T-IOL
- Status last verified
- Apr 2015
- First submitted
- 29 Mar 2015
- Last updated
- 9 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ferrer-Blasco T, Montes-Mico R, Peixoto-de-Matos SC, Gonzalez-Meijome JM, Cervino A. Prevalence of corneal astigmatism before cataract surgery. J Cataract Refract Surg. 2009 Jan;35(1):70-5. doi: 10.1016/j.jcrs.2008.09.027.
PubMed 19101427Rashad KM. Laser in situ keratomileusis for myopic astigmatism. J Refract Surg. 1999 Nov-Dec;15(6):653-60. doi: 10.3928/1081-597X-19991101-09.
PubMed 10590003Novis C. Astigmatism and toric intraocular lenses. Curr Opin Ophthalmol. 2000 Feb;11(1):47-50. doi: 10.1097/00055735-200002000-00007.
PubMed 10724827Chang DF. Early rotational stability of the longer Staar toric intraocular lens: fifty consecutive cases. J Cataract Refract Surg. 2003 May;29(5):935-40. doi: 10.1016/s0886-3350(02)01843-6.
PubMed 12781279Lane SS, Burgi P, Milios GS, Orchowski MW, Vaughan M, Schwarte E. Comparison of the biomechanical behavior of foldable intraocular lenses. J Cataract Refract Surg. 2004 Nov;30(11):2397-402. doi: 10.1016/j.jcrs.2004.03.041.
PubMed 15519095Lombardo M, Carbone G, Lombardo G, De Santo MP, Barberi R. Analysis of intraocular lens surface adhesiveness by atomic force microscopy. J Cataract Refract Surg. 2009 Jul;35(7):1266-72. doi: 10.1016/j.jcrs.2009.02.029.
PubMed 19545819Lane SS, Ernest P, Miller KM, Hileman KS, Harris B, Waycaster CR. Comparison of clinical and patient-reported outcomes with bilateral AcrySof toric or spherical control intraocular lenses. J Refract Surg. 2009 Oct;25(10):899-901. doi: 10.3928/1081597X-20090617-05. Epub 2009 Oct 12.
PubMed 19835331Koshy JJ, Nishi Y, Hirnschall N, Crnej A, Gangwani V, Maurino V, Findl O. Rotational stability of a single-piece toric acrylic intraocular lens. J Cataract Refract Surg. 2010 Oct;36(10):1665-70. doi: 10.1016/j.jcrs.2010.05.018.
PubMed 20870111Entabi M, Harman F, Lee N, Bloom PA. Injectable 1-piece hydrophilic acrylic toric intraocular lens for cataract surgery: efficacy and stability. J Cataract Refract Surg. 2011 Feb;37(2):235-40. doi: 10.1016/j.jcrs.2010.08.040.
PubMed 21241904Visser N, Bauer NJ, Nuijts RM. Toric intraocular lenses: historical overview, patient selection, IOL calculation, surgical techniques, clinical outcomes, and complications. J Cataract Refract Surg. 2013 Apr;39(4):624-37. doi: 10.1016/j.jcrs.2013.02.020.
PubMed 23522584Shimizu K, Misawa A, Suzuki Y. Toric intraocular lenses: correcting astigmatism while controlling axis shift. J Cataract Refract Surg. 1994 Sep;20(5):523-6. doi: 10.1016/s0886-3350(13)80232-5.
PubMed 7996408Till JS, Yoder PR Jr, Wilcox TK, Spielman JL. Toric intraocular lens implantation: 100 consecutive cases. J Cataract Refract Surg. 2002 Feb;28(2):295-301. doi: 10.1016/s0886-3350(01)01035-5.
PubMed 11821213Dick HB, Krummenauer F, Trober L. [Compensation of corneal astigmatism with toric intraocular lens: results of a multicentre study]. Klin Monbl Augenheilkd. 2006 Jul;223(7):593-608. doi: 10.1055/s-2006-926652. German.
PubMed 16855943Stewart CM, McAlister JC. Comparison of grafted and non-grafted patients with corneal astigmatism undergoing cataract extraction with a toric intraocular lens implant. Clin Exp Ophthalmol. 2010 Nov;38(8):747-57. doi: 10.1111/j.1442-9071.2010.02336.x.
PubMed 20497428Chang DF. Comparative rotational stability of single-piece open-loop acrylic and plate-haptic silicone toric intraocular lenses. J Cataract Refract Surg. 2008 Nov;34(11):1842-7. doi: 10.1016/j.jcrs.2008.07.012.
PubMed 19006728
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotational Stability After Nanoflex Collamer Toric Intraocular Lens Implantation in Astigmatic Patients Undergoing Cataract Surgery
- ClinicalTrials.gov ID
- NCT02412215
- Acronym / sponsor ID
- T-IOL / 0026769
- Conditions
- Astigmatism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 9 Apr 2015 (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.
This study aims to assess the rotational stability of the new collameric Nanoflex toric intraocular lens (T-IOL) by STAAR inserted in astigmatic patients after cataract surgery.
The purpose of this study is also to determine whether the use of a toric intraocular lens (T-IOL) improves visual acuity.
Detailed description
A good rotational stability of toric intraocular lenses (T-IOL) allows an accurate refractive correction. However, many aspects -both pre-operative and post-operative- can interfere causing T-IOL rotation and misalignment.
Complete preoperative ocular evaluation is performed including slit-lamp examination, uncorrected distance visual acuity (UDVA), best-corrected visual acuity (BCVA), Javal keratometry, corneal Scheimplug tomography (Pentacam), optical biometry (IOL Master), Goldman applanation tonometry and fundus evaluation through dilated pupils. The spherical IOL power is calculated considering the axial length obtained with optical biometry, the magnitude of astigmatism derived from Javal keratometry and the steepest axis obtained with corneal tomography. The power of the toric IOL is determined with the online Staar Toric IOL calculator. The reference landmarks are also marked preoperatively with a sterile methylene blue fine point pen. The marking is rechecked in the operating theatre with the electronic toric marker ASICO.
Postoperative evaluation for IOL alignment and rotational stability is performed with slit-lamp photography on dilated pupils. Images are captured with Haag Streit slit lamp BQ 900 and are evaluated with the image-analysis software Protractor (Staar).
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toric Nanoflex IOL | Experimental | Procedure: Phacoemulsification with toric Nanoflex IOL implantation, Device: NanoFlex toric Intraocular LensPhacoemulsification with toric Nanoflex IOL implantation |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of 60 years of age ore more
- Cataract
- Corneal astigmatism of 1 diopter (D) or more
Key exclusion criteria (6 listed)
- Primary or secondary pathological conditions of the cornea
- Zonular fibres pathologies (phacodonesis, pseudoexfoliation syndrome)
- Irregular astigmatism (corneal scar, keratoconus, pterygium)
- Traumatic cataract
- Previous ocular surgery
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 |
|---|---|---|
| Phacoemulsification with toric Nanoflex IOL implantationA self-sealing incision is made with a 2.2mm knife at 110°. Phacoemulsification is performed. The foldable nanoFlex toric IOL is injected in the capsular bag using the nanoPoint single-use injector system (STAAR) or 1620 sofTip Injector (ASICO). The IOL is rotated to align the cylinder axis with the steep corneal meridian using Z align function by Callisto Eye. Every movement of the IOL axis marks are noted. | Procedure or surgery | Toric Nanoflex IOL |
| NanoFlex toric Intraocular Lens | Device | Toric Nanoflex IOL |
Primary outcome
Change in rotational stability of the toric intraocular lens (T-IOL).
Time frame: Change of rotational stability at 1 day, 1 week, 1 month, 3 months, 6 months, 12 months and 18 months after surgery.
The misalignment of the lens is defined as the difference (Δ) between the intended axis and the actual axis of the new collameric Nanoflex T-IOL by STAAR.
1 secondary outcome
Correction of the astigmatism.
Time frame: Change in visual acuity at 1 day, 1 week, 1 month, 3 months, 6 months, 12 months and 18 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2015.
- Background: PubMed 19101427Ferrer-Blasco T, Montes-Mico R, Peixoto-de-Matos SC, Gonzalez-Meijome JM, Cervino A. Prevalence of corneal astigmatism before cataract surgery. J Cataract Refract Surg. 2009 Jan;35(1):70-5. doi: 10.1016/j.jcrs.2008.09.027.
- Background: PubMed 10590003Rashad KM. Laser in situ keratomileusis for myopic astigmatism. J Refract Surg. 1999 Nov-Dec;15(6):653-60. doi: 10.3928/1081-597X-19991101-09.
- Background: PubMed 10724827Novis C. Astigmatism and toric intraocular lenses. Curr Opin Ophthalmol. 2000 Feb;11(1):47-50. doi: 10.1097/00055735-200002000-00007.
- Background: PubMed 12781279Chang DF. Early rotational stability of the longer Staar toric intraocular lens: fifty consecutive cases. J Cataract Refract Surg. 2003 May;29(5):935-40. doi: 10.1016/s0886-3350(02)01843-6.
- Background: PubMed 15519095Lane SS, Burgi P, Milios GS, Orchowski MW, Vaughan M, Schwarte E. Comparison of the biomechanical behavior of foldable intraocular lenses. J Cataract Refract Surg. 2004 Nov;30(11):2397-402. doi: 10.1016/j.jcrs.2004.03.041.
- Background: PubMed 19545819Lombardo M, Carbone G, Lombardo G, De Santo MP, Barberi R. Analysis of intraocular lens surface adhesiveness by atomic force microscopy. J Cataract Refract Surg. 2009 Jul;35(7):1266-72. doi: 10.1016/j.jcrs.2009.02.029.
- Background: PubMed 19835331Lane SS, Ernest P, Miller KM, Hileman KS, Harris B, Waycaster CR. Comparison of clinical and patient-reported outcomes with bilateral AcrySof toric or spherical control intraocular lenses. J Refract Surg. 2009 Oct;25(10):899-901. doi: 10.3928/1081597X-20090617-05. Epub 2009 Oct 12.
- Background: PubMed 20870111Koshy JJ, Nishi Y, Hirnschall N, Crnej A, Gangwani V, Maurino V, Findl O. Rotational stability of a single-piece toric acrylic intraocular lens. J Cataract Refract Surg. 2010 Oct;36(10):1665-70. doi: 10.1016/j.jcrs.2010.05.018.
- Background: PubMed 21241904Entabi M, Harman F, Lee N, Bloom PA. Injectable 1-piece hydrophilic acrylic toric intraocular lens for cataract surgery: efficacy and stability. J Cataract Refract Surg. 2011 Feb;37(2):235-40. doi: 10.1016/j.jcrs.2010.08.040.
- Background: PubMed 23522584Visser N, Bauer NJ, Nuijts RM. Toric intraocular lenses: historical overview, patient selection, IOL calculation, surgical techniques, clinical outcomes, and complications. J Cataract Refract Surg. 2013 Apr;39(4):624-37. doi: 10.1016/j.jcrs.2013.02.020.
- Background: PubMed 7996408Shimizu K, Misawa A, Suzuki Y. Toric intraocular lenses: correcting astigmatism while controlling axis shift. J Cataract Refract Surg. 1994 Sep;20(5):523-6. doi: 10.1016/s0886-3350(13)80232-5.
- Background: PubMed 11821213Till JS, Yoder PR Jr, Wilcox TK, Spielman JL. Toric intraocular lens implantation: 100 consecutive cases. J Cataract Refract Surg. 2002 Feb;28(2):295-301. doi: 10.1016/s0886-3350(01)01035-5.
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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.
Antonio M Fea, MD, PhD principal investigator
Department of Surgical Sciences, Ophthalmology Institute, University of Turin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phacoemulsification with toric Nanoflex IOL implantation and NanoFlex toric Intraocular Lens in people with Astigmatism, run by University of Turin, Italy at 1 site in Italy.
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 3 inclusion and 6 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 9 Apr 2015. 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 Italy. 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 Antonio M Fea, MD, PhD (+39 011 566 6039, antoniomfea@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in rotational stability of the toric intraocular lens (T-IOL). (time frame: Change of rotational stability at 1 day, 1 week, 1 month, 3 months, 6 months, 12 months and 18 months after surgery.). 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 NCT02412215, which also lists 33 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 9 Apr 2015.