Rotational Stability After Nanoflex Collamer Toric Intraocular Lens Implantation in Astigmatic Patients

Astigmatism Clinical Trial

— T-IOL  

Official title:

Rotational Stability After Nanoflex Collamer Toric Intraocular Lens Implantation in Astigmatic Patients Undergoing Cataract Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02412215
• Other study ID #: 0026769
• Status: Recruiting
• Phase: N/A
• First received: March 29, 2015
• Last updated: April 8, 2015
• Start date: March 2015
• Est. completion date: September 2017

Study information

• Verified date: April 2015
• Source: University of Turin, Italy
• Contact: Antonio M Fea, MD, PhD
• Phone: +39 011 566 6039
• Email: antoniomfea[@]gmail.com
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Patients of 60 years of age ore more

• Cataract

• Corneal astigmatism of 1 diopter (D) or more

Exclusion Criteria:

• 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Astigmatism

Intervention

Procedure:
• Phacoemulsification with toric Nanoflex IOL implantation
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.

Device:
• NanoFlex toric Intraocular Lens

Locations

Country	Name	City	State
Italy	Ophthalmology Institute, University of Turin	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (33)

Alió JL, Agdeppa MC, Pongo VC, El Kady B. Microincision cataract surgery with toric intraocular lens implantation for correcting moderate and high astigmatism: pilot study. J Cataract Refract Surg. 2010 Jan;36(1):44-52. doi: 10.1016/j.jcrs.2009.07.043. — View Citation

Bachernegg A, Rückl T, Riha W, Grabner G, Dexl AK. Rotational stability and visual outcome after implantation of a new toric intraocular lens for the correction of corneal astigmatism during cataract surgery. J Cataract Refract Surg. 2013 Sep;39(9):1390-8. doi: 10.1016/j.jcrs.2013.03.033. Epub 2013 Jul 2. — View Citation

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Cha D, Kang SY, Kim SH, Song JS, Kim HM. New axis-marking method for a toric intraocular lens: mapping method. J Refract Surg. 2011 May;27(5):375-9. doi: 10.3928/1081597X-20101005-01. Epub 2010 Oct 15. — View Citation

Chang 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. — View Citation

Chang DF. Early rotational stability of the longer Staar toric intraocular lens: fifty consecutive cases. J Cataract Refract Surg. 2003 May;29(5):935-40. — View Citation

Chassain C. [Evaluation of visual performance after implantation of a double C-Loop toric intraocular lens]. J Fr Ophtalmol. 2014 Sep;37(7):507-13. doi: 10.1016/j.jfo.2014.02.007. Epub 2014 Aug 13. French. — View Citation

Chua WH, Yuen LH, Chua J, Teh G, Hill WE. Matched comparison of rotational stability of 1-piece acrylic and plate-haptic silicone toric intraocular lenses in Asian eyes. J Cataract Refract Surg. 2012 Apr;38(4):620-4. doi: 10.1016/j.jcrs.2011.10.037. Epub 2012 Jan 31. — View Citation

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Entabi 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. — View Citation

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Kim MH, Chung TY, Chung ES. Long-term efficacy and rotational stability of AcrySof toric intraocular lens implantation in cataract surgery. Korean J Ophthalmol. 2010 Aug;24(4):207-12. doi: 10.3341/kjo.2010.24.4.207. Epub 2010 Aug 3. — View Citation

Koshy 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. — View Citation

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Lane 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. — View Citation

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Shah GD, Praveen MR, Vasavada AR, Rampal NV, Vasavada VA, Asnani PK, Pandita D. Software-based assessment of postoperative rotation of toric intraocular lens. J Cataract Refract Surg. 2009 Mar;35(3):413-8. doi: 10.1016/j.jcrs.2008.10.057. — View Citation

Shimizu K, Misawa A, Suzuki Y. Toric intraocular lenses: correcting astigmatism while controlling axis shift. J Cataract Refract Surg. 1994 Sep;20(5):523-6. — View Citation

Stewart CM, McAlister JC. Comparison of grafted and non-grafted patients with corneal astigmatism undergoing cataract extraction with a toric intraocular lens implant. Clin Experiment Ophthalmol. 2010 Nov;38(8):747-57. doi: 10.1111/j.1442-9071.2010.02336.x. — View Citation

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Waltz KL, Featherstone K, Tsai L, Trentacost D. Clinical outcomes of TECNIS toric intraocular lens implantation after cataract removal in patients with corneal astigmatism. Ophthalmology. 2015 Jan;122(1):39-47. doi: 10.1016/j.ophtha.2014.06.027. Epub 2014 Nov 18. — View Citation

Weinand F, Jung A, Stein A, Pfützner A, Becker R, Pavlovic S. Rotational stability of a single-piece hydrophobic acrylic intraocular lens: new method for high-precision rotation control. J Cataract Refract Surg. 2007 May;33(5):800-3. — View Citation

* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in rotational stability of the toric intraocular lens (T-IOL).	The misalignment of the lens is defined as the difference (?) between the intended axis and the actual axis of the new collameric Nanoflex T-IOL by STAAR.	Change of rotational stability at 1 day, 1 week, 1 month, 3 months, 6 months, 12 months and 18 months after surgery.	No
Secondary	Correction of the astigmatism.	Effective correction evaluated through corrected distance visual acuity (CDVA) and uncorrected distance visual acuity (UDVA).	Change in visual acuity at 1 day, 1 week, 1 month, 3 months, 6 months, 12 months and 18 months after surgery	No

External Links

•   U.S. Food and Drug administration, summary Information for: ACRYSOF® Toric Posterior Chamber Intraocular Lens - 930014/S015 - P930014/S015.