Clinical trial NCT04420429: The Effect Of Preoperative Parameters On Success After DMEK Surgery
Official title: The Effect Of Preoperative Anterior Segment Parameters On Success After Descemet Membrane Endothelial Keratoplasty (Dmek) Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fuchs' Endothelial Dystrophy
Pseudophakic Bullous Keratopathy
Descemet's Membrane; Defect
Herpetic Keratitis
Angle's Classification
Endothelial Dysfunction
Keywords: Descemet Membrane
anterior chamber depth
axial length
endothelial count
Descemet membrane endothelial keratoplasty
Lead sponsor: Beyoglu Eye Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2020-06-09
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who developed pseudophakic bullous keratopathy, Fuchs endothelial dystrophy, endothelial insufficiency after herpetic endotheliitis and associated permanent corneal edema and therefore DMEK surgery.

Brief summary: The aim of this study is to evaluate the effect of preoperative parameters on surgical results in Descemet Membrane Endothelial Keratoplasty (DMEK) surgery.

Detailed description: In patients undergoing Descemet Membrane Endothelial Keratoplasty (DMEK) surgery; preoperative anterior chamber depth, angle parameters, axial length and corneal parameters will be evaluated. The effects of these parameters on surgical results will be examined.

Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo Descemet membrane endothelial keratoplasty(DMEK)
* aged 18 old older

Exclusion Criteria:

* Patients with corneal pathology other than endothelial insufficiency
* Glaucoma patients,
* Patients who have previously had any keratoplasty procedure

Primary outcomes:
measure: Change in visual acuity
timeFrame: Baseline and after surgery 1, 3, 6, and 12 months
measure: Change in endothelial cell density
timeFrame: after surgery 1, 3, 6, and 12 months
Secondary outcomes:
measure: Change in maximum (steepest) and minimum (flattest) keratometry values in the central corneal zone
timeFrame: Baseline and after surgery 1, 3, 6, and 12 months
measure: Change in anterior chamber depth
timeFrame: Baseline and after surgery 1, 3, 6, and 12 months
measure: Change in axial length
timeFrame: Baseline and after surgery 1, 3, 6, and 12 months
measure: Change in central pachymetry
timeFrame: Baseline and after surgery 1, 3, 6, and 12 months
measure: Change in intraocular pressure
timeFrame: Baseline and after surgery 1, 3, 6, and 12 months
Other outcomes:
measure: Surgical complications
timeFrame: During surgery
Locations:
city: Istanbul
country: Turkey
facility: Beyoğlu Eye Training and Research Hospital
Study officials:
affiliation: Beyoglu Eye Training and Research Hospital
name: Semih Çakmak, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cakmak S, Kirgiz A, Yildirim Y, Taskoparan S, Genc S, Agca A. The effect of anterior segment parameters on surgical success of Descemet membrane endothelial keratoplasty: a prospective study. Int Ophthalmol. 2023 Jan;43(1):197-205. doi: 10.1007/s10792-022-02416-0. Epub 2022 Jul 10.