Negative DysphotopsiaNCT02724553
Comparison of Haptic Orientation in Negative Dysphotopsia
A study testing Acrylic lens implantation in people with Negative Dysphotopsia, run by Loma Linda University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Negative Dysphotopsia
- What is being tested?
- Acrylic lens implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
About this study
Official title: 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.
- Conditions
- Negative Dysphotopsia
- Being tested
- Acrylic lens implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acrylic lens implantationDevice
| Study group | Role | What they receive |
|---|---|---|
| Vertical orientation of Haptic orientation | Other | The orientation of the IOL haptic will be implanted in the vertical position during routine cataract surgery Receives: Device: Acrylic lens implantation |
| Horizontal orientation of Haptic orientation | Other | The orientation of the IOL haptic will be implanted in the horizontal position during routine cataract surgery Receives: Device: Acrylic lens implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of negative dysphotopsia after cataract surgery at 6 months
Presence of negative dysphotopsia in the vertical IOL placement compared to horizontal IOL placement
Measured: 6 months
Secondary outcomes (2)
Presence of negative dysphotopsia after cataract surgery at 1 week
Presence of negative dysphotopsia in the vertical IOL placement compared to horizontal IOL placement
Measured: 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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: A recent publication answered the study question being asked
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Negative DysphotopsiaStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Howard D Guan, MD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724553
- Sponsor's protocol ID
- 5150345
- Status last verified
- Nov 2016
- First submitted
- 26 Feb 2016
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 22727295Narvaez 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.
PubMed 15899465Masket 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.
PubMed 21700100Vamosi 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.
PubMed 20202539Osher 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.
PubMed 18812121Burke 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.
PubMed 24957929Trattler 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.
PubMed 15899464Cooke 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.
PubMed 20362862
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Horizontal and Vertical IOL Haptic Orientation in Negative Dysphotopsia.
- ClinicalTrials.gov ID
- NCT02724553
- Acronym / sponsor ID
- 5150345
- Conditions
- Negative Dysphotopsia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: A recent publication answered the study question being asked
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 31 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vertical orientation of Haptic orientation | Other | Device: Acrylic lens implantationThe orientation of the IOL haptic will be implanted in the vertical position during routine cataract surgery |
| Horizontal orientation of Haptic orientation | Other | Device: Acrylic lens implantationThe orientation of the IOL haptic will be implanted in the horizontal position during routine cataract surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acrylic lens implantation | Device | Horizontal orientation of Haptic orientation, Vertical orientation of Haptic orientation |
Primary outcome
Presence of negative dysphotopsia after cataract surgery at 6 months
Time frame: 6 months
Presence of negative dysphotopsia in the vertical IOL placement compared to horizontal IOL placement
2 secondary outcomes
Presence of negative dysphotopsia after cataract surgery at 1 week
Time frame: 1 week
Presence of negative dysphotopsia after cataract surgery at 1 month
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2016.
- Background: PubMed 22727295Holladay 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.
- Background: PubMed 15899465Narvaez 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.
- Background: PubMed 21700100Masket 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.
- Background: PubMed 20202539Vamosi 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.
- Background: PubMed 18812121Osher 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.
- Background: PubMed 24957929Burke 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.
- Background: PubMed 15899464Trattler 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.
- Background: PubMed 20362862Cooke 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard D Guan, MD principal investigator
Loma Linda University
Questions about this trial
What is this clinical trial studying?
A study testing Acrylic lens implantation in people with Negative Dysphotopsia, run by Loma Linda University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of negative dysphotopsia after cataract surgery at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02724553, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2016.