Clinical decision making in patients with cataract and Fuchs* endothelial dystrophy (FED): validation of in vivo confocal microscopy backscatter and OCT as a predictive measurements to decide to perform a phaco- or triple procedure.

Clinical decision making in patients with cataract and Fuchs* endothelial dystrophy (FED): validation of in vivo confocal microscopy backscatter and OCT as a predictive measurements to decide to perform a phaco- or triple procedure. - Clinical decisions in patients with cataract and FED

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42593

Enrollment

Registered

2015-04-23

Start date

2015-06-23

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

Cataract and FED

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age >= 18 years. - Informed consent. - FED stage = 2. - Cataract requiring surgery. - Visual acuity (VA)

Exclusion criteria

Exclusion criteria: - Indication for triple procedure. - History of other ocular disorders affecting VA. - History of intra-ocular, corneal or refractive surgery. - Severe nystagmus. - Corneal opacity in the pre-pupillary region not related to FED. - Corneal neovascularization > 1 quadrant. - Amblyopia. - Expected VA after surgery

Design outcomes

Primary

Measure	Time frame
Preoperative corneal backscatter; postoperative number of patients requiring PLK (y/n).	—

Secondary

Measure	Time frame
Preoperative: - LOCS III classification of cataract. Preoperative and one month postoperative: - OCT grayscale of the corneal stroma. - Best corrected visual acuity (BCVA; ETDRS). - Pachymetry (Tomey). - Contrast sensitivity (CS; Pelli-Robson). - Straylight (C-Quant). - VFQ-25 questionnaire. Perioperative: - Phaco time and energy.	—

Countries

Netherlands

Outcome results