Rotational Stability After Nanoflex Collamer Toric Intraocular Lens Implantation in Astigmatic Patients
NCT ID: NCT02412215
Last Updated: 2015-04-09
Study Results
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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UNKNOWN
NA
60 participants
INTERVENTIONAL
2015-03-31
2017-09-30
Brief Summary
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The purpose of this study is also to determine whether the use of a toric intraocular lens (T-IOL) improves visual acuity.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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Toric Nanoflex IOL
Phacoemulsification with toric Nanoflex IOL implantation
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.
NanoFlex toric Intraocular Lens
Interventions
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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.
NanoFlex toric Intraocular Lens
Eligibility Criteria
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Inclusion Criteria
* Cataract
* Corneal astigmatism of 1 diopter (D) or more
Exclusion Criteria
* Zonular fibres pathologies (phacodonesis, pseudoexfoliation syndrome)
* Irregular astigmatism (corneal scar, keratoconus, pterygium)
* Traumatic cataract
* Previous ocular surgery
* Complications during cataract surgery
60 Years
ALL
No
Sponsors
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University of Turin, Italy
OTHER
Responsible Party
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Antonio Fea
Antonio Fea MD. PhD
Principal Investigators
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Antonio M Fea, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Surgical Sciences, Ophthalmology Institute, University of Turin
Locations
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Ophthalmology Institute, University of Turin
Turin, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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0026769
Identifier Type: -
Identifier Source: org_study_id
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