Comparison of Haptic Orientation in Negative Dysphotopsia

Comparison of Horizontal and Vertical IOL Haptic Orientation in Negative Dysphotopsia.

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.

Study Overview

• Status: Withdrawn
• Conditions: Negative Dysphotopsia
• Intervention / Treatment: Device: Acrylic lens implantation

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Vertical orientation of Haptic orientation; The orientation of the IOL haptic will be implanted in the vertical position during routine cataract surgery	Device: Acrylic lens implantation
Other: Horizontal orientation of Haptic orientation; The orientation of the IOL haptic will be implanted in the horizontal position during routine cataract surgery	Device: Acrylic lens implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of negative dysphotopsia after cataract surgery at 6 months	Presence of negative dysphotopsia in the vertical IOL placement compared to horizontal IOL placement	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of negative dysphotopsia after cataract surgery at 1 week	Presence of negative dysphotopsia in the vertical IOL placement compared to horizontal IOL placement	1 week
Presence of negative dysphotopsia after cataract surgery at 1 month	Presence of negative dysphotopsia in the vertical IOL placement compared to horizontal IOL placement	1 month

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Howard D Guan, MD, Loma Linda University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: February 26, 2016
• First Submitted That Met QC Criteria: March 24, 2016
• First Posted (Estimate): March 31, 2016

Study Record Updates

• Last Update Posted (Estimate): November 30, 2016
• Last Update Submitted That Met QC Criteria: November 28, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 5150345

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No