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The use of neutral density filters in PlusoptiX devices.

A study to the determine the use of neutral density filter for reliable measurements in very large pupils in use of the plusoptiX software, and the influence of those filters on outcomes.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON25950
Enrollment
41
Registered
2011-02-23
Start date
2010-09-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pupil size. Refractive outcome. SEQ. Score of neutral density filter.

Interventions

Measurements are made with the Powerrefractor II
software installed of the PlustoptiX A09. Both for the un- and dilated: A entry measurement with and without glasses will be made. Thereafter three measurements will be made with glasses and consecuti
91% (Newport Ltd), 79% (Newport Ltd), 62% (Thorlabs Ltd), 46% (Thorlabs Ltd) and 34% (Thorlabs Ltd).

Sponsors

Medisch Centrum Haaglanden.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Un-dilated pupils: Healthy volunteers, aged 35 to 60 years, having hypermetropia corrected with unifocal glasses, visiting the department Ophthalmology either as a patient or as an accompanying person. Dilated pupils: Healthy volunteers, aged 18 to 60, having hypermetropia, which received cycloplegics.

Exclusion criteria

Exclusion criteria: For both un-dilated and dilated subjects: Cataract and/or vitreous bleeding, and/or abnormal shaped pupils or no oral consent. For un-dilated subjects pupil sizes 7.8mm. For dilated subjects pupil sizes <6mm.

Design outcomes

Primary

MeasureTime frame
1. Success and failure rates of the consecutive neutral density filters; 2. (&#916;) SEQ values. Differences will be considered statistical significant if p0.2 diopters &#916; SEQ (1 and 2) will be considered clinical significant.

Contacts

Public ContactH.M. (Ellen) Minderhout, van

Postbus 432

van.minderhout@gmail.com

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)