Trial Comparing Cataract Surgery With Triple-DMEK in Patients With Cataract and Fuchs Endothelial Corneal Dystrophy

ConditionsCataract Surgery Cataract and Fuchs Endothelial Corneal Dystrophy

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Cologne

About this trial

The purpose of the study is to investigate whether there is a difference in BCVA in patients who receive one of the following two surgeries: intervention group (arm 1) cataract surgery alone and control group (arm 2) cataract surgery combined with removal of the diseased endothelial cells and the attached Descemet's membrane followed by transplantation of a healthy endothelial cell layer with attached Descemet's membrane ("triple-DMEK" group; comparator therapy).

The secondary objectives are to compare the two surgical methods with regard to other visual functions and optical as well as morphological differences, to safety, to quality of life, and to safety.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with FECD and nuclear cataract in study eye

Male and female patients ≥18 years of age

Subject must be able to understand and read the national language.

Written informed consent prior to any study-related procedures

Disqualifiers

Patients with ocular and/or systemic comorbidity affecting vision or clinically proven anterior and/or posterior segment disease other than FECD and cataract (exclusion of macular disease or edema by OCT)

Iris synechiae, pupil diameter <6 mm after dilatation, pseudoexfoliation syndrome, subluxated lens, previous history of ocular trauma/surgery or inflammatory disease

Subjective diurnal changes in visual acuity with worse visual acuity in the morning

Corneal (epithelial) edema visible at slit lamp examination

Trial design

Design model

Parallel

Treatments tested in this trial

Intervention group /arm 1 (Cataract surgery alone)
Procedure/Surgery
Cataract surgery (arm 1) is performed using a small incision technique. The tunnel is used both for cataract surgery and for implantation of the DMEK graft (arm 2). The centres confirmed that the main incision will be localized between 11 and 12 o'clock and will have a width of 2.4 to 2.8 mm. A tunnel suture will only be placed if there is leakage from the incisions. If cataract surgery alone (arm 1) is performed, a thin dispersive viscoelastic is applied to the endothelium for protection before phacoemulsification. A hydrophobic acrylic monofocal IOL will be implanted into the bag. The centers confirmed that Barret Universal II formula is the standard IOL calculation formula for both groups and for all axial lengths.
Control group /arm 2: Corneal transplantation as Descemet Membrane Endothelial Keratoplasty (DMEK) in combination with cataract surgery (triple-DMEK)
Procedure/Surgery
After cataract surgery DMEK is continued using the surgeon's standard technique for graft implantation and unfolding in triple-DMEK. In all cases the graft will be implanted using the same main incision as for IOL implantation. Once the DMEK graft is unrolled and attached to the posterior corneal stroma the complete anterior chamber will be filled with SF6 20%.

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: Experimental intervention /arm 1Experimental treatment 1 intervention

Group B: Control intervention /arm2Other 1 intervention

Trial outcomes

Primary outcomes

BCVA 22

Best corrected visual acuity (BCVA) is messured with EDTRS-charts (transformed to logMAR)

Time frame

22 weeks +/- 14 days after surgery

Secondary outcomes

Change in visual acuity (BCVA)

Specific measurement variable: ETDRS-charts (transformed to logMAR); Analysis metric (participant level): Difference value at follow-up- baseline value Method of aggregation (summary measure for each study group): Mean difference

Time frame

Baseline (pre-op) and 22 weeks +/- 14 days after initial surgery

Contrast sensitivity

Specific measurement variable: Total score of Freiburg Vision Test "FrACT"; Analysis metric (participant level): Value Method of aggregation (summary measure for each study group): Mean

Time frame

22 weeks +/- 14 days after initial surgery

Change in contrast sensitivity

Specific measurement variable: Total score of Freiburg Vision Test "FrACT"; Analysis metric (participant level): Difference Value at follow-up-baseline value; Method of aggregation (summary measure for each study group): Mean difference

Time frame

22 weeks +/- 14 days after initial surgery

Optical quality measured by HD-analyzer

Specific measurement variable: Total score of objective scattering index (OSI); Analysis metric (participant level): Value Method of aggregation (summary measure for each study group): Mean

Time frame

22 weeks +/- 14 days after initial surgery