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Comparison of Haptic Orientation in Negative Dysphotopsia

NCT ID: NCT02724553

Last Updated: 2016-11-30

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-11-30

Brief Summary

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Previous studies attempted to understand the dysphotopsia phenomenon by examining intraocular lens type, anterior capsule depth, iris-to-lens depth, lens refractive material, clear cornea incision wounds and anterior capsulorrhexis. However, there is limited literature in understanding haptic orientation and negative dysphotopsia; postulated theories and anecdotal reports relate to horizontal haptic orientation and the lateralization of rays such that light is received both in smaller width and anterior to the peripheral retina; however, no formal studies currently exist.

Detailed Description

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Conditions

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Negative Dysphotopsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Vertical orientation of Haptic orientation

The orientation of the IOL haptic will be implanted in the vertical position during routine cataract surgery

Group Type OTHER

Acrylic lens implantation

Intervention Type DEVICE

Horizontal orientation of Haptic orientation

The orientation of the IOL haptic will be implanted in the horizontal position during routine cataract surgery

Group Type OTHER

Acrylic lens implantation

Intervention Type DEVICE

Interventions

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Acrylic lens implantation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: Patients with bilateral cataracts that are visually significant meeting standard criteria for removal and select standard monofocal lens implantation.

Exclusion Criteria: Patients with any prior refractive surgery including prior cataract surgery, corneal ocular pathology, iris atrophy/damage, retinal or optic nerve pathology. Patients with history of peripheral vision loss. Patients selecting multifocal or toric lens implantation.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Howard D Guan, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

References

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Holladay JT, Zhao H, Reisin CR. Negative dysphotopsia: the enigmatic penumbra. J Cataract Refract Surg. 2012 Jul;38(7):1251-65. doi: 10.1016/j.jcrs.2012.01.032.

Reference Type BACKGROUND
PMID: 22727295 (View on PubMed)

Narvaez J, Banning CS, Stulting RD. Negative dysphotopsia associated with implantation of the Z9000 intraocular lens. J Cataract Refract Surg. 2005 Apr;31(4):846-7. doi: 10.1016/j.jcrs.2004.08.059.

Reference Type BACKGROUND
PMID: 15899465 (View on PubMed)

Masket S, Fram NR. Pseudophakic negative dysphotopsia: Surgical management and new theory of etiology. J Cataract Refract Surg. 2011 Jul;37(7):1199-207. doi: 10.1016/j.jcrs.2011.02.022.

Reference Type BACKGROUND
PMID: 21700100 (View on PubMed)

Vamosi P, Csakany B, Nemeth J. Intraocular lens exchange in patients with negative dysphotopsia symptoms. J Cataract Refract Surg. 2010 Mar;36(3):418-24. doi: 10.1016/j.jcrs.2009.10.035.

Reference Type BACKGROUND
PMID: 20202539 (View on PubMed)

Osher RH. Negative dysphotopsia: long-term study and possible explanation for transient symptoms. J Cataract Refract Surg. 2008 Oct;34(10):1699-707. doi: 10.1016/j.jcrs.2008.06.026.

Reference Type BACKGROUND
PMID: 18812121 (View on PubMed)

Burke TR, Benjamin L. Sulcus-fixated intraocular lens implantation for the management of negative dysphotopsia. J Cataract Refract Surg. 2014 Sep;40(9):1469-72. doi: 10.1016/j.jcrs.2013.11.037. Epub 2014 Jun 20.

Reference Type BACKGROUND
PMID: 24957929 (View on PubMed)

Trattler WB, Whitsett JC, Simone PA. Negative dysphotopsia after intraocular lens implantation irrespective of design and material. J Cataract Refract Surg. 2005 Apr;31(4):841-5. doi: 10.1016/j.jcrs.2004.12.044.

Reference Type BACKGROUND
PMID: 15899464 (View on PubMed)

Cooke DL. Negative dysphotopsia after temporal corneal incisions. J Cataract Refract Surg. 2010 Apr;36(4):671-2. doi: 10.1016/j.jcrs.2010.01.004.

Reference Type BACKGROUND
PMID: 20362862 (View on PubMed)

Other Identifiers

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5150345

Identifier Type: -

Identifier Source: org_study_id