Primary objective: - Uncovering the underlying optical origin of ND.Secondary objectives:- Determining the key aspects of IOL design to prevent ND- Develop a Virtual Refractive Surgery application for the prevention and treatment of ND.
ID
Source
Brief title
Condition
- Vision disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The measured and ray-traced peripheral aberrations and their relation to the
symptoms described in the questionnaires.
Secondary outcome
- A description of the effect of different IOL designs on negative dysphotopsia.
- Description of the progression/regression of negative dysphotopsia in the
first year after cataract surgery.
- The assessment of the potential clinical value of static perimetry to
quantify the visual field loss in ND.
- The assessment of the performance of the eye models for unusual eyes.
Background summary
Negative Dysphotopsia (ND) is a complication that presents itself after an
otherwise uncomplicated cataract surgery. During cataract surgery the original
crystalline lens, which has become clouded, is extracted and replaced by an
artificial *intraocular* lens (IOL). ND is manifested as a persistent dark
shadow in the patients* visual field. Due to the lack of knowledge on the
origin of ND, no effective method to prevent or treat this condition is
currently available. This study aims to fill this gap through the optical
simulations using patient-specific models of the eye, based on MRI and corneal
topography data. With these eye-models we aim to uncover the cause of ND and
subsequently assess the efficacy of different treatment options through
ray-tracing simulations.
Study objective
Primary objective:
- Uncovering the underlying optical origin of ND.
Secondary objectives:
- Determining the key aspects of IOL design to prevent ND
- Develop a Virtual Refractive Surgery application for the prevention and
treatment of ND.
Study design
A single center, causal research, non-blinded, prospective study.
Study burden and risks
The study evaluation consists of an extensive ophthalmic evaluation
complemented by an ocular-MRI scan and two short questionnaires. The amount of
evaluation points differs for each study group:
- The subjects without ND: 1 evaluation
- The subjects with recently developed ND (<3 months): 3 evaluations
- The subjects with persistent ND (>3 months), who are scheduled for an IOL
exchange or an piggyback IOL implantation as a part of their treatment: 2
evaluations
- The subjects with persistent ND (>3 months) who have already had unsuccessful
treatment before: 1 evaluation
- The subjects with abnormally shaped eyes or very high refractive errors: 1
evaluation.
The risks associated with participation are the potential risks involved with
the high magnetic fields present around an MRI scanner. As all subjects will be
screened for potential contra-indication for MR-scanning, all potential risks
of this study are effectively removed.
There will be no direct benefit for the subjects in this study. However, it
will contribute to the knowledge of ND, which might benefit the patients with
ND in the future.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
1. Age *18 years
2. Gender: both male and female
3. Uncomplicated cataract surgery
4. For the groups with ND: complaints of negative dysphotopsia following cataract surgery
5. For the group without ND: no complaints of negative dysphotopsia following cataract surgery
Exclusion criteria
1. Age <18 years;2. Prior refractive surgery, for instance:
a. Phakic IOL implantation
b. Laser eye surgery, including:
I. LASEK
II. LASIK
III. PRK;3. Conditions limiting the visual field, for instance:
a. Glaucoma
b. Retinal ablation;4. Conditions limiting the visual acuity which are expected to hinder an accurate ray-tracing analysis by the physician or investigators, for instance corneal diseases.;5. Contraindications to MRI scanning, including:
a. Claustrophobia
b. Pregnancy
c. Pacemakers and defibrillators
d. Nerve stimulators
e. Intracranial clips
f. Metallic fragments
g. Cochlear implants
h. Ferromagnetic implants
i. Hydrocephalus pump
j. Permanent make-up
k. Tattoos above the shoulders
l. Piercings (unless they can be taken out)
m. Subjects who cannot keep their head still (eg. Tremor, Parkinson*s disease)
n. Severe physical restriction (completely wheelchair dependent);In the case of uncertainty about the MRI-contraindications, the MR-safety commission of the radiology department will decide whether this subject can be included in the study or not.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL58358.058.16 |