NCT05345652

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2024

Completed
Last Updated

April 26, 2022

Status Verified

April 1, 2022

Enrollment Period

1.9 years

First QC Date

March 29, 2022

Last Update Submit

April 19, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

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

    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 Outcomes (1)

  • To Improve sugery

    6 months after the surgery

Interventions

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

Also known as: DALK

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 31279005BACKGROUND
  • 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.

    PMID: 31571625BACKGROUND
  • 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.

MeSH Terms

Conditions

KeratoconusCorneal DiseasesCorneal Opacity

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • momen A Mohammad, Lecturer

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Mahmoud M Ismael, professor

CONTACT

Abd el nasser A Mohammad, professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 29, 2022

First Posted

April 26, 2022

Study Start

May 1, 2022

Primary Completion

March 29, 2024

Study Completion

September 29, 2024

Last Updated

April 26, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study Protocol Access