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Rotation of an Intraocular Lens - HOYA Vivinex iSert P261 (Rot P261)

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ClinicalTrials.gov Identifier: NCT03157375
Recruitment Status : Completed
First Posted : May 17, 2017
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
Rupert Menapace, Medical University of Vienna

Brief Summary:

Age-related cataract is the main cause of impaired vision in the elderly population worldwide. In the UK, more than half of people who are over 65 years old have some cataract development in one or both eyes. The only treatment that can restore functional visual ability is cataract surgery where the opacified crystalline lens is removed by phacoemulsification and an artificial intraocular lens is implanted. It is estimated that around 10 million cataract operations are performed around the world each year. Cataract operations are generally very successful, with a low risk of serious complications.

During the past two decades, cataract surgery underwent tremendous change and modernisation resulting in today's small incision phacoemulsification surgery and a safe technique with a short rehabilitation time for the patient. Traditional spherical monofocal intraocular lenses (IOLs) restore best-corrected vision and may lessen the need for spectacles. These IOLs correct only the spherical portion of the total refractive error and do not correct corneal astigmatism. Astigmatism is a visually disabling refractive error affecting the general population, especially those with cataract. At least 15% to 20% of cataract patients have 1.5 diopters (D) or more of corneal or refractive astigmatism. With increased patient expectations, the trend is not only to remove the cataract but also to address the problem of pre-existing astigmatism at the time of surgery.

Surgical-induced astigmatism can be reduced by smaller incisions, i.e. microincision cataract surgery (MICS), which by definition is surgery performed through incisions smaller than 2.0 mm, reducing the need for suturing. This results in better corneal optical quality, thus improving visual outcomes. There are also other surgical options to correct preexisting astigmatism during cataract surgery like: selectively positioning of the phacoemulsification incision; astigmatic keratotomy with corneal or limbal relaxing incisions; excimer laser refractive procedures such as photorefractive keratectomy, laser in situ keratomileusis, and laser-assisted subepithelial keratectomy; or implanting pseudophakic toric posterior chamber intraocular lenses (IOLs).

Toric IOLs have been shown to result in good visual and refractive outcomes. Combined with MICS, these IOLs can allow effective correction of cylindrical errors intraoperatively, improving visual quality and thus leading to spectacle independence. Plate haptic and loop haptic toric IOLs have been considered for about a decade but have been associated with postoperative rotational instability. Rotation of a toric lens from its intended orientation degrades its corrective power, with approximately 3.3% loss of cylindrical power for every degree off axis. A misorientation of approximately 30° negates the effectiveness of astigmatic correction, and a misorientation of more than 30° may induce additional astigmatism. Although some patients are asymptomatic despite induced astigmatism, others experience symptoms such as blurred or distorted vision, headache, fatigue, eyestrain, squinting, or eye discomfort. Thus, IOL orientation stability is an essential goal in toric IOL design.

RATIONALE

The purpose of this study is to assess the axial IOL rotation and optical quality (refraction, visual acuity, contrast sensitivity, decentration and tilt) and capsular bag reaction after micro-incision surgery with an IOL implantation in cataract patients - HOYA Vivinex iSert® model P261.


Condition or disease Intervention/treatment Phase
Intraocular Lens Device: Intraocular Lens Implantation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rotation of an Intraocular Lens - HOYA Vivinex iSert P261
Study Start Date : October 6, 2014
Actual Primary Completion Date : October 2, 2015
Actual Study Completion Date : October 2, 2015

Arm Intervention/treatment
Implantation of the intraocular lens Vivinex p261 on axis 0°
Device: Intraocular Lens Implantation
45°
Implantation of the intraocular lens Vivinex p261 on axis 45°
Device: Intraocular Lens Implantation
90°
Implantation of the intraocular lens Vivinex p261 on axis 90°
Device: Intraocular Lens Implantation
135°
Implantation of the intraocular lens Vivinex p261 on axis 135°
Device: Intraocular Lens Implantation



Primary Outcome Measures :
  1. Change of axial intraocular lens position [ Time Frame: 7 months ]
    Change in axial intraocular lens position from end of surgery (baseline axis) to 4-7 months (end of study visit)



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Uni- or bilateral age-related cataract necessitating phacoemulsification extraction and posterior IOL implantation
  • Need for spherical IOL correction between 15.00 and 25.00 D
  • Pupil dilation of ≥ 6.5 mm
  • Age 50 and older

Exclusion Criteria:

  • Corneal abnormality
  • Pseudoexfoliation
  • Preceding ocular surgery or trauma
  • Uncontrolled glaucoma
  • Proliferative diabetic retinopathy
  • Iris neovascularization
  • History of uveitis/iritis
  • Microphthalmus
  • Recurrent intraocular inflammation of unknown etiology
  • Blind fellow eye
  • Uncontrolled systemic or ocular disease
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03157375


Locations
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Austria
Medical University Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna

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Responsible Party: Rupert Menapace, Prof.Dr. Rupert Menapace, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03157375     History of Changes
Other Study ID Numbers: EK 1437/2014
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017

Keywords provided by Rupert Menapace, Medical University of Vienna:
IOL, IOL Rotation, Axial Rotation