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Evaluation of the safety and tolerability of the primary posterior capsulotomy during femtosecond laser-assisted cataract surgery

Evaluation of the safety and tolerability of the primary posterior capsulotomy during femtosecond laser-assisted cataract surgery - PPLC

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00010845
Enrollment
33
Registered
2016-08-03
Start date
2015-04-09
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

H26.9 H26.4

Interventions

Group 1: Cataract Surgery of both eyes. The first eye is operated with the standard manual method and additionally supplied with the primary posterior capsulotomy by femtosecond laser after successful

Sponsors

Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH Augenklinik
Lead Sponsor

Eligibility

Sex/Gender
All
Age
22 Years to No maximum

Inclusion criteria

Inclusion criteria: - Visus limiting lens opacities (grade 1 - 4 LOCS III classification, Lens opacities Classification System) - Cataract-related visual acuity of 0.8 or less - Patients aged> 22 years

Exclusion criteria

Exclusion criteria: - Active inflammation or infection of the anterior or posterior segment of the eye - People with a single eye - Malformations or eye tumor - Advanced Glaucoma - Pseudoexfoliation Syndrome - Advanced diabetic retinopathy - Wet AMD - Dilated pupil size of less than 6.0 mm - Intraoperative Floppy Iris Syndrome (IFIS) - Pregnant and nursing mothers - Participation in another study in the last 30 days

Design outcomes

Primary

MeasureTime frame
Retinal thickness (center thickness, central minimum central maximum, central volume, measuring diameter 1, 3 and 6 mm) using optical coherence tomography (SD-OCT Spectralis, Heidelberg Engineering) at time points: preoperative and postoperative 1 week, 8 weeks, 6 months

Secondary

MeasureTime frame
Refraction by standard method (preoperatively and postoperatively one week, 8 weeks, 6 months) Intraocular pressure by I-Care tonometer (preoperatively, and postopativ 1 weeks, 8 weeks, 6 months) Secondary cataract by slit-lamp examination and photographic documentation for the graphical evaluation (postopativ 1 weeks, 8 weeks, 6 months) Laser flare measurement by Kowa Laserflaremeter (postoperative 1 day, 3 days, 1 week)

Countries

Germany

Contacts

Public ContactYesim Häußler-Sinangin

Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH

yesim.sinangin@kk-bochum.de+49-(0)234-299-3142

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026