Negative Dysphotopsia Clinical Trial
Official title:
Comparison of Horizontal and Vertical IOL Haptic Orientation in Negative Dysphotopsia.
| Verified date | November 2016 |
| Source | Loma Linda University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | November 2016 |
| Est. primary completion date | November 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Loma Linda University |
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Narváez 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. — View Citation
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. — View Citation
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. — View Citation
Vámosi P, Csákány B, Németh 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |