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Effect of optical quality on retinal thresholds


- candidate number27702
- NTR NumberNTR6631
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-jul-2017
- Secondary IDs201700546 UMCG Research Register
- Public TitleEffect of optical quality on retinal thresholds
- Scientific TitleEffect of optical quality on retinal thresholds
- ACRONYM
- hypothesisTo determine the influence of optical quality on perimetry for phakic and pseudophakic healthy and glaucoma patients.

To determine the influence of CLE on perimetry and optical quality for PAC patients.
- Healt Condition(s) or Problem(s) studiedGlaucoma
- Inclusion criteriaPhakic and pseudophakic POAG and PACG patients and phakic PAC patients scheduled for CLE, who visit the ophthalmology clinic at University Medical Center Groningen, that have provided the signed informed consent form and meet the inclusion-exclusion criteria. Healthy subjects between ages 50 and 75, who have provided the signed informed consent form and returned the questionnaire with results which do not indicate ophthalmic abnormalities.
- Exclusion criteriaPOAG patients
Visual acuity less than 0.8
Axial length lower than 23mm
History of closed or blocked angle
Myopia higher than 5D
For pseudophakic patients only, IOL model implanted different than Tecnis Monofocal, Model ZCB00

Phakic PACG patients
Visual acuity less than 0.8
Axial length higher than 23mm
For pseudophakic patients only, IOL model implanted different than Tecnis Monofocal, Model ZCB00

Phakic PCA scheduled for CLE
Visual acuity less than 0.8
Non-glaucomatous visual field loss
IOL model to be implanted different than Tecnis Monofocal, Model ZCB00
Axial length higher than 23mm


Healthy Subjects
Visual acuity less than 0.8
Corneal refractive (LASIK, LASEK, RK, PRK, etc.)
Any visual field loss
Intraocular pressure above 21 mmHg
Positive family history of glaucoma
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blinding[default]
- control[default]
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-jan-2018
- planned closingdate1-aug-2018
- Target number of participants40
- InterventionsNo
- Primary outcomeRetinal sensitivity thresholds, measured by means of perimetry, as a function of ocular aberrations.
- Secondary outcomeChange in retinal sensitivity thresholds, measured by means of perimetry, as a function of ocular aberrations before and after clear lens extraction in PAC patients

Other
Corneal aberrations, ocular biometry, ocular scatter, intraocular pressure, visual acuity and refraction. Cases and controls are matched for age and gender; visual field damage and refraction are used for descriptive statistics, to characterize the study population.
- Timepointsn/a
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES L. Scanferla
- CONTACT for SCIENTIFIC QUERIES Catarina Rodrigues Joao
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- Publications
- Brief summaryThe impact of optical aberrations on perimetry may be different in healthy eyes than in glaucoma patients. Although the visual loss for the last group is mainly due to the disease, it is important to understand which level of optical quality has an impact on perimetry for these patients and whether this may depend on the type of glaucoma.

Therefore, we propose the current study to further understand these factors. The main study parameter of this research is the relation between optical quality and perimetry in healthy and glaucoma eyes, both PACG and POAG. We intend to include both phakic and pseudophakic patients in each group. This is to cover a wider range of peripheral optical quality because current IOL technology increases peripheral aberrations.

The current study is also aimed to have additional outcome variables. CLE has been suggested as a therapy for PAC. However, there are no reports in the literature of the optical and visual performance of PAC patients after CLE. Therefore, an additional outcome variable is to study the effect of pseudophakia on ocular aberrations and perimetry for PAC patients. We propose to measure PAC patients undergoing CLE before and after the surgery, so that, we can relate how a change in optical quality translates into perimetry for the same subject.
- Main changes (audit trail)
- RECORD31-jul-2017 - 25-aug-2017


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