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NCT Number: NCT04420429

The Effect Of Preoperative Parameters On Success After DMEK Surgery

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

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Key information

Conditions

Fuchs' Endothelial Dystrophy Angle's Classification Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corneal Diseases Corneal Dystrophies, Hereditary DNA Virus Infections Descemet's Membrane; Defect Endothelial Dysfunction Eye Diseases Eye Diseases, Hereditary Eye Infections Eye Infections, Viral Genetic Diseases, Inborn Herpes Simplex Herpesviridae Infections Herpetic Keratitis Infections Keratitis Keratitis, Herpetic Malocclusion Pseudophakic Bullous Keratopathy Stomatognathic Diseases Tooth Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beyoğlu Eye Training and Research Hospital

Istanbul, 34420, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Descemet membrane endothelial keratoplasty (DMEK)

Procedure

All participants underwent DMEK surgery

Primary outcomes

  1. Change in visual acuity

    Time frame: Baseline and after surgery 1, 3, 6, and 12 months

    Change from baseline

  2. Change in endothelial cell density

    Time frame: after surgery 1, 3, 6, and 12 months

    Change from baseline

Secondary outcomes

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

    Time frame: Baseline and after surgery 1, 3, 6, and 12 months

    Change from baseline

  2. Change in anterior chamber depth

    Time frame: Baseline and after surgery 1, 3, 6, and 12 months

    Change from baseline

  3. Change in axial length

    Time frame: Baseline and after surgery 1, 3, 6, and 12 months

    Change from baseline

  4. Change in central pachymetry

    Time frame: Baseline and after surgery 1, 3, 6, and 12 months

    Change from baseline

  5. Change in intraocular pressure

    Time frame: Baseline and after surgery 1, 3, 6, and 12 months

    Change from baseline

Other outcomes

  1. Surgical complications

    Time frame: During surgery

    Complications occurring during the surgery will be recorded.

Sponsors and collaborators

Lead sponsor

Beyoglu Eye Research and Education Hospital

Other Gov

Registry information

Official study title

The Effect Of Preoperative Anterior Segment Parameters On Success After Descemet Membrane Endothelial Keratoplasty (Dmek) Surgery

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jun 9, 2020
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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