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

NCT ID: NCT05345652

Last Updated: 2022-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-01

Study Completion Date

2024-09-29

Brief Summary

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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

Detailed Description

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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.

Conditions

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Keratoconus Cornea Corneal Opacity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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deep anterior lamellar keratoplasty

DALK is a partial-thickness corneal transplant which involves only the donor stroma, leaving the recipient's own Descemet's membrane and endothelium

Intervention Type PROCEDURE

Other Intervention Names

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DALK

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ali Omar Mohamed Ali

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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momen A Mohammad, Lecturer

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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Mahmoud M Ismael, professor

Role: CONTACT

01223793159

Abd el nasser A Mohammad, professor

Role: CONTACT

01124888838

References

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Hos D, Matthaei M, Bock F, Maruyama K, Notara M, Clahsen T, Hou Y, Le VNH, Salabarria AC, Horstmann J, Bachmann BO, Cursiefen C. Immune reactions after modern lamellar (DALK, DSAEK, DMEK) versus conventional penetrating corneal transplantation. Prog Retin Eye Res. 2019 Nov;73:100768. doi: 10.1016/j.preteyeres.2019.07.001. Epub 2019 Jul 3.

Reference Type BACKGROUND
PMID: 31279005 (View on PubMed)

Singh R, Gupta N, Vanathi M, Tandon R. Corneal transplantation in the modern era. Indian J Med Res. 2019 Jul;150(1):7-22. doi: 10.4103/ijmr.IJMR_141_19.

Reference Type BACKGROUND
PMID: 31571625 (View on PubMed)

Krumeich JH, Knulle A, Krumeich BM. [Deep anterior lamellar (DALK) vs. penetrating keratoplasty (PKP): a clinical and statistical analysis]. Klin Monbl Augenheilkd. 2008 Jul;225(7):637-48. doi: 10.1055/s-2008-1027485. German.

Reference Type RESULT
PMID: 18642207 (View on PubMed)

Study Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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Ant. segment OCT in DALK

Identifier Type: -

Identifier Source: org_study_id

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