KeratoconusNCT05345652
Evaluation Of Deep Anterior Lamellar Keratoplasty By Anterior Segment Ocular Coherence Tomography
An observational study of Keratoconus and Cornea, run by Assiut University.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Keratoconus, Cornea, Corneal Opacity
- What is being tested?
- deep anterior lamellar keratoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 29 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Older than 18 years old and younger than 60 in need for dalk
Who may be able to join
- Patients undergoing DALK surgery older than 18 years old ( keratoconus and corneal opacity ).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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:
- Primary (main): To evaluate the post-operative changes after DALK surgery through ant segment OCT and its relation to clinical findings.
- 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
- Keratoconus, Cornea, Corneal Opacity
- Being tested
- deep anterior lamellar keratoplasty
- Medical subject headings
- Keratoconus, Corneal Diseases, Corneal Opacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep anterior lamellar keratoplastyProcedure or surgery
Also called DALK
DALK is a partial-thickness corneal transplant which involves only the donor stroma, leaving the recipient's own Descemet's membrane and endothelium
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after the surgery
Secondary outcomes (1)
To Improve sugery
To improve the post operative best corrected visual acuity .
Measured: 6 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start1 May 2022 (estimated)
- Primary completion29 Mar 2024 (estimated)
- Study completion29 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Omar Mohamed Ali, Assiut University
- Investigators
- momen A Mohammad, Lecturer, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345652
- Sponsor's protocol ID
- Ant. segment OCT in DALK
- Status last verified
- Apr 2022
- First submitted
- 29 Mar 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 31279005Singh 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 31571625Krumeich 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Deep Anterior Lamellar Keratoplasty By Anterior Segment Ocular Coherence Tomography
- ClinicalTrials.gov ID
- NCT05345652
- Acronym / sponsor ID
- Ant. segment OCT in DALK
- Conditions
- Keratoconus, Cornea, Corneal Opacity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 29 Mar 2024 (estimated)
- Study completion
- 29 Sep 2024 (estimated)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- Primary (main): To evaluate the post-operative changes after DALK surgery through ant segment OCT and its relation to clinical findings.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Older than 18 years old and younger than 60 in need for dalk
Key inclusion criteria (1 listed)
- Patients undergoing DALK surgery older than 18 years old ( keratoconus and corneal opacity ).
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| deep anterior lamellar keratoplastyAlso: DALKDALK is a partial-thickness corneal transplant which involves only the donor stroma, leaving the recipient's own Descemet's membrane and endothelium | Procedure or surgery | – |
Primary outcome
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.
1 secondary outcome
To Improve sugery
Time frame: 6 months after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Background: PubMed 31279005Hos 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.
- Background: PubMed 31571625Singh 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.
- Results publication: PubMed 18642207Krumeich 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
momen A Mohammad, Lecturer study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Keratoconus and Cornea, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud M Ismael, professor (01223793159, eyesofcairo@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05345652, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.