Evaluation Of Deep Anterior Lamellar Keratoplasty By Anterior Segment Ocular Coherence Tomography

April 19, 2022 updated by: Ali Omar Mohamed Ali, Assiut University
Investigators' research is concerned observing the post-operative anterior segment OCT changes throughout the post- operative follow up of the patient and relating to improve the visual outcome of the surgery which is the goal of surgery

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …):

  • Complete medical and ocular history, including patients' age, sex, type of pathology of the cornea such as keratoconus, opacity , history of previous corneal intervention , and other ocular surgeries.
  • Thorough ophthalmological examination, including visual acuity, intraocular pressure (IOP) measuring by Goldman applanation tonometer (Haag Streit, Koeniz, Switzerland), slit lamp biomicroscopic examination of anterior segment, investigations for keratoconus as pentacam , preoperative anterior segment OCT if needed , slit lamp photography for the cornea .

Candidate patients will be operated through DALK , then will be examined post operative clinically and be followed up at 3 months , 6 months for best corrected visual acuity, Intraocular pressure , refraction , graft healing , and anterior segment OCT for the anterior chamber angel , graft healing , descemet's membrane state , tear film . The interpretation of the clinical data with the changes in the ant. Segment OCT will give us the clue to get the best visual outcome of surgery .

2.4.5 -Research outcome measures:

  1. Primary (main):

    To evaluate the post-operative changes after DALK surgery through ant segment OCT and its relation to clinical findings.

  2. Secondary (subsidiary): To improve the outcome of the surgery through the graft creation , stitching of the graft , following up the IOP clinically and state of AC angel through OCT , the tear film and changes after surgery , all these factors to improve the target of the surgery which is the post operative best corrected visual acuity .

Data collection Data to be collected include patients' age, sex, cause of corneal surgery ,BCVA, IOP levels, clinical examination of the eye and if there are findings , and ant. Segment OCT of the eye Computer software Data analysis will be done via SPSS version 26 windows 10 Statistical tests Data will be statistically described in terms of mean, SD, and range when appropriate. Comparisons between the preoperative and postoperative data will be done using Student's t-test. Study groups' comparisons will be done using Student's t-test for independent normally distributed samples data.

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Older than 18 years old and younger than 60 in need for dalk

Description

Inclusion Criteria:

  • Patients undergoing DALK surgery older than 18 years old ( keratoconus and corneal opacity ).

Exclusion Criteria:

  • Patients suffering from active corneal ulcer
  • Active infection.
  • Posterior segment diseases.
  • Recent ocular surgery in the study eye in the 2 months prior to enrolment,
  • Media opacities as vitreous haemorrhage,
  • Vasculitis , patients with macular edema related to, glaucoma, chronic uveitis, or pre-existing ocular pathologic features or abnormalities.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the post-operative changes after DALK surgery through ant segment OCT and its relation to clinical findings.
Time Frame: 6 months after the surgery
To evaluate the post-operative changes after DALK surgery through ant segment OCT and its relation to clinical findings.
6 months after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To Improve sugery
Time Frame: 6 months after the surgery
To improve the post operative best corrected visual acuity .
6 months after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: momen A Mohammad, Lecturer, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2022

Primary Completion (Anticipated)

March 29, 2024

Study Completion (Anticipated)

September 29, 2024

Study Registration Dates

First Submitted

March 29, 2022

First Submitted That Met QC Criteria

April 19, 2022

First Posted (Actual)

April 26, 2022

Study Record Updates

Last Update Posted (Actual)

April 26, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ant. segment OCT in DALK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Study Data/Documents

  1. Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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