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Status unknownNCT05345652Updated Apr 26, 2022

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

An observational study in Keratoconus, Cornea and Corneal Opacity, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-04-26.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 60 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Keratoconus
  • Cornea
  • Corneal Opacity
03

In context

Keratoconus

313 studies on the registry are indexed under Keratoconus; 56 are open to participants now.

This study's planned enrollment of 20 is below the median of 130 across 97 observational studies indexed under Keratoconus.

Browse Keratoconus studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Assiut University studies →

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

04

Who can participate

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

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Interventions

  • Proceduredeep 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

    Also known as: DALK

06

What researchers measure

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.

    Time frame: 6 months after the surgery

Secondary outcomes

  1. To Improve sugery

    To improve the post operative best corrected visual acuity .

    Time frame: 6 months after the surgery

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 31279005 ↗
  • 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. PubMed 31571625 ↗
  • 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. PubMed 18642207 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for May 2022; primary completion for Mar 2024, 22 months later.

Of 33 non-industry observational studies under Keratoconus, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 204. This study's planned 22 months is close to that.

Counting every sponsor, half of 36 studies reached it within 30 months; a quarter within 13 and three quarters within 95.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 29, 2022
First posted
Apr 26, 2022
StartEst.
May 1, 2022
Primary completionEst.
Mar 29, 2024
CompletionEst.
Sep 29, 2024
Last update
Apr 26, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05345652
Lead sponsor
Assiut University
Responsible party
Ali Omar Mohamed Ali (Principal Investigator, Assiut University) — Principal investigator
First posted
Apr 26, 2022
Start date
May 1, 2022 (estimated)
Primary completion
Mar 29, 2024 (estimated)
Completion
Sep 29, 2024 (estimated)
Last update
Apr 26, 2022

Study contacts

Mahmoud M Ismael, professor
Contact
eyesofcairo@hotmail.com
01223793159
Abd el nasser A Mohammad, professor
Contact
abdelnasser2009@yahoo.com
01124888838
momen A Mohammad, Lecturer
study director · Assiut University

Oversight

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

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