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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Hypertension
• Ocular Hypertension
• Unrecognized Condition

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