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.

Completed

Conditions: Cataract and FED
10015917

Registration Number: NL-OMON42593

Lead Sponsor: Oogziekenhuis Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

- Age >= 18 years.
- Informed consent.
- FED stage = 2.
- Cataract requiring surgery.
- Visual acuity (VA) < 0.7.

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 < 0.6.
- Fellow eye already included in this study.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Preoperative corneal backscatter; postoperative<br /><br>number of patients requiring PLK (y/n).</p><br>

Secondary Outcome Measures

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