Incidence and Management of Ocular Hypertension Following Deep Anterior Lamellar Keratoplasty

NCT ID: NCT04931316

Last Updated: 2021-06-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-15
• Study Completion Date: 2021-10-20

Brief 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.

Detailed 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.

Conditions

Unrecognized Condition

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

antiglaucoma

use antiglaucoma in ocular hypertension

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• patients who were diagnosed with elevated IOP after DALK surgery performed from 2018 to 2020

Exclusion Criteria

• Patients with penetrating keratoplasty

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Amgad Mahmoud El Nokrashy

Lecturer of Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

AHMED El WEHEDY, MD

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Hatem El Awady, MD

Role: STUDY_CHAIR

Mansoura University

AYA HASHISH, MD

Role: STUDY_CHAIR

Mansoura University

AMGAD EL NOKRASHY, MD

Role: STUDY_CHAIR

Mansoura University

Locations

Mansoura university

Al Mansurah, Dakahlyia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Amgad El Nokrashy, MD

Role: CONTACT

amgad.ali@mans.edu.eg

00201022187736

Aya Hashish, MD

Role: CONTACT

aya.hashish@mans.edu.eg

00201004701791

Facility Contacts

Amgad El Nokrashy, MD

Role: primary

amgad.ali@mans.edu.eg

00201022187736

Other Identifiers

R.20.12.1121

Identifier Type: -

Identifier Source: org_study_id