An interventional study of Phacoemulsification with toric Nanoflex IOL implantation and NanoFlex toric Intraocular Lens in Astigmatism, sponsored by University of Turin, Italy. Status unknown at 1 site in Italy. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2015-04-09.
Sponsored by University of Turin, Italy · Not applicable and Interventional
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.
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).
413 studies on the registry are indexed under Astigmatism; 55 are open to participants now.
This study's planned enrollment of 60 is close to the median of 55 across 321 interventional studies indexed under Astigmatism.
Browse Astigmatism studies →University of Turin, Italy is the lead sponsor of 206 studies on the registry; 34 are open to participants now.
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Phacoemulsification with toric Nanoflex IOL implantation
Procedure: Phacoemulsification with toric Nanoflex IOL implantation · Device: NanoFlex toric Intraocular Lens
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.
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.
Time frame: Change of rotational stability at 1 day, 1 week, 1 month, 3 months, 6 months, 12 months and 18 months after surgery.
Correction of the astigmatism.
Effective correction evaluated through corrected distance visual acuity (CDVA) and uncorrected distance visual acuity (UDVA).
Time frame: Change in visual acuity at 1 day, 1 week, 1 month, 3 months, 6 months, 12 months and 18 months after surgery
This study is status unknown, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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University of Turin, Italy