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NCT04931316 Clinical Trial

Incidence and Management of Ocular Hypertension Following Deep Anterior Lamellar Keratoplasty

Unrecognized Condition Clinical Trial

— Dalk  

Official title:
Incidence and Management of Ocular Hypertension Following Deep Anterior Lamellar Keratoplasty

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04931316
Other study ID # R.20.12.1121
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 15, 2021
Est. completion date October 20, 2021

Study information
Verified date June 2021
Source Mansoura University
Contact Amgad El Nokrashy, MD
Phone 00201022187736
Email amgad.ali@mans.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a retrospective case series study that included patients who performed deep anterior lamellar keratoplasty and presented with elevated intraocular pressure during follow up.

Description:

This is a retrospective case series study that included patients who performed deep anterior lamellar keratoplasty and presented with elevated intraocular pressure during follow up. Patients' demographic characteristics, medical, and ocular history will be recorded. Inclusion criteria will include patients who were diagnosed with elevated intraocular pressure (IOP) after DALK surgery performed from 2018 to 2020 with follow up duration more than 6 months. Patients with less than 6 months of follow-up will be excluded from the study. Patients' demographic characteristics, medical and ocular history will be recorded. Baseline complete ophthalmic examination was performed. It included best corrected visual acuity (BCVA) using Landolt C chart that was converted to log minimum angle of resolution (log MAR) for statistical analysis, slit lamp anterior segment examination (with attention to cornea, bulbar conjunctiva and AC), intraocular pressure measurement using rebound system (I care tonometer, Topcon, Canada), angle assessment and fundus examination using Goldman 3 mirror contact lens. High IOP was defined as intraocular pressure more than 25 mmHg. Data will be collected with attention to appropriate management done either medical treatment or surgical intervention.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date October 20, 2021
Est. primary completion date September 20, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - patients who were diagnosed with elevated IOP after DALK surgery performed from 2018 to 2020 Exclusion Criteria: - Patients with penetrating keratoplasty

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• antiglaucoma
use antiglaucoma in ocular hypertension

Locations
Country Name City State
Egypt Mansoura university Mansoura Dakahlyia

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intraocular pressure values assessment of intraocular pressure after lamellar keratoplasty this is a retrospective study . collection of data from patients records over 2 months
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