To determine the efficacy of quantification of vitreous floaters captured by SLO-imaging technique for Nd:YAG vitreolysis for persisting vitreous floaters.
ID
Source
Brief title
Condition
- Eye disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Reduction of floater area measured on SLO-image at six months after first laser
treatment.
Secondary outcome
Safety.
Number of treatments (1, 2 or 3).
Applied laser energy per treatment session.
Visual acuity (logMAR).
OCT: optic nerve and the macula (cystoid macular edema y/n).
Intraocular pressure.
Fundusphotograph.
Peripheral retinal exam.
Visual function questionnaire VFQ-25.
Floater questionnaire (see Appendix).
Background summary
Presently, pars plana vitrectomy (PPV) is the standard treatment for floaters
causing serious complaints; patient satisfaction is high. However, many
ophthalmologists are somewhat reluctant to operate on eyes with normal (or
hardly reduced) VA due to the risk of complications. An alternative treatment,
the Nd:YAG laser, has a better safety profile than PPV but appears to be only
moderately efficacious. A generally accepted test to quantify complaints may
help to develop a preferred practice pattern for vitreous floaters.
Study objective
To determine the efficacy of quantification of vitreous floaters captured by
SLO-imaging technique for Nd:YAG vitreolysis for persisting vitreous floaters.
Study design
Prospective, observational study.
Study burden and risks
Participants do not benefit. Risks are negligible; burden is minimal. Required
extra time is maximally 2.5 hours.
Schiedamse Vest 180
Rotterdam 3011 BH
NL
Schiedamse Vest 180
Rotterdam 3011 BH
NL
Listed location countries
Age
Inclusion criteria
Age >= 18 years.
Informed consent.
Floaters not adjacent to the lens or retina (> 2 mm).
Complaints lasting > 3 months.
Vitreous floaters are PVD related.
Exclusion criteria
History of glaucoma, uveitis, macular degeneration, retinal defect (eye to be treated or fellow-eye), macular edema, vascular retinal disease.
Other condition causing increased straylight, such as corneal haze, guttata, corneal surgery, refractive surgery, cataract affecting vision, PCO, contact lenses, iris diaphany, peripheral iridectomy/iridotomy.
Design
Recruitment
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 | NL52882.078.15 |