The Effect Of Preoperative Parameters On Success After DMEK Surgery

NCT04420429 | Completed

• 1 other identifier: BeyogluEREH
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Change in visual acuity

  Change from baseline

  Baseline and after surgery 1, 3, 6, and 12 months

• Change in endothelial cell density

  Change from baseline

  after surgery 1, 3, 6, and 12 months

Secondary Outcomes (5)

• Change in maximum (steepest) and minimum (flattest) keratometry values in the central corneal zone

  Baseline and after surgery 1, 3, 6, and 12 months

• Change in anterior chamber depth

  Baseline and after surgery 1, 3, 6, and 12 months

• Change in axial length

  Baseline and after surgery 1, 3, 6, and 12 months

• Change in central pachymetry

  Baseline and after surgery 1, 3, 6, and 12 months

• Change in intraocular pressure

  Baseline and after surgery 1, 3, 6, and 12 months

Other Outcomes (1)

• Surgical complications

  During surgery

Study Arms (1)

Cohort

All patients

Procedure: Descemet membrane endothelial keratoplasty (DMEK)

Interventions

Descemet membrane endothelial keratoplasty (DMEK) PROCEDURE

All participants underwent DMEK surgery

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beyoglu Eye Research and Education Hospital: lead

Study Sites (1)

Beyoğlu Eye Training and Research Hospital

Istanbul, 34420, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 35810243 DERIVED

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy; Keratitis, Herpetic; Malocclusion

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Eye Infections, Viral; Eye Infections; Infections; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Keratitis; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Semih Çakmak, MD

  Beyoglu Eye Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 16, 2020
• First Posted: June 9, 2020
• Study Start: June 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: July 10, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)