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Status unknownNCT04931316DalkUpdated Jun 23, 2021

Incidence and Management of Ocular Hypertension Following Deep Anterior Lamellar Keratoplasty

An observational study in Unrecognized Condition, sponsored by Mansoura University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-06-23.

Sponsored by Mansoura University · Observational

The sponsor has not verified this record recently (last verified Jun 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
10
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Unrecognized Condition
03

In context

Ocular Hypertension

649 studies on the registry are indexed under Ocular Hypertension; 48 are open to participants now.

This study's planned enrollment of 10 is below the median of 142 across 98 observational studies indexed under Ocular Hypertension.

Browse Ocular Hypertension studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with DALK

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with penetrating keratoplasty
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
10 participants (estimated)
Patient registry
No

Interventions

  • Otherantiglaucoma

    use antiglaucoma in ocular hypertension

06

What researchers measure

Primary outcomes

  1. Intraocular pressure values

    assessment of intraocular pressure after lamellar keratoplasty

    Time frame: this is a retrospective study . collection of data from patients records over 2 months

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Study locations

1 of 1 sites recruiting
  • Mansoura university
    Mansoura, Dakahlyia, Egypt
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04931316
Lead sponsor
Mansoura University
Responsible party
Amgad Mahmoud El Nokrashy (Lecturer of Ophthalmology, Mansoura University) — Principal investigator
First posted
Jun 18, 2021
Start date
Mar 15, 2021
Primary completion
Sep 20, 2021 (estimated)
Completion
Oct 20, 2021 (estimated)
Last update
Jun 23, 2021

Study contacts

Amgad El Nokrashy, MD
Contact
amgad.ali@mans.edu.eg
00201022187736
Aya Hashish, MD
Contact
aya.hashish@mans.edu.eg
00201004701791
AHMED El WEHEDY, MD
principal investigator · Mansoura University
Hatem El Awady, MD
study chair · Mansoura University
AYA HASHISH, MD
study chair · Mansoura University
AMGAD EL NOKRASHY, MD
study chair · Mansoura University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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