KeratoconusPhase 2/3NCT04457063
Endothelial Cell Loss After Penetrating Keratoplasty
A Phase 2/3 study testing PKP in people with Keratoconus, run by Alexandria University at 1 site in Egypt.
Trial summary
This work aimed at the assessment of corneal endothelial cell loss after toric ICL implantation for correction of myopia and astigmatism after penetrating keratoplasty. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Keratoconus
- What is being tested?
- PKP
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2018to 15 Jun 2020
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PKP for keratoconus, and then toric ICL was implanted after minimum of one year with stable refraction
Who cannot join
- Less than 18 and unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endothelial Cell Loss Following Toric ICL Implantation for Correction of Myopia and Astigmatism After Penetrating Keratoplasty
This work aimed at the assessment of corneal endothelial cell loss after toric ICL implantation for correction of myopia and astigmatism after penetrating keratoplasty.
Read the detailed description
Penetrating keratoplasty (PKP) is considered a safe and effective procedure.This work aimed at the assessment of corneal endothelial cell loss after toric ICL implantation for correction of myopia and astigmatism after penetrating keratoplasty.
- Conditions
- Keratoconus
- Being tested
- PKP
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PKPProcedure or surgery
- The horizontal axis was marked with a pointed marker at the slit lamp immediately before surgery.
- TICL loading into the STAAR injector cartridge
- Temporal clear corneal 3 mm incision \& 2-side ports then viscoelastic injection into the AC
- Implantation of the TICL using the injector, then rotation according to the implantation diagram guided with Mendez protractor, and lastly placement of the haptics under the iris.
- Pupil constriction with A.Ch.
- Washing the viscoelastic \&Wound hydration.
- Topical antibiotic steroids (Vigamox and Tobradex) 4 times /day for 3weeks
| Study group | Role | What they receive |
|---|---|---|
| penetrating keratoplasty | Experimental | A prospective non-comparative non-randomized clinical study which was conducted on 12 eyes of 8 patients 4 males and 4 females who underwent PKP for keratoconus, and then toric ICL was implanted after minimum of one year with stable refraction Receives: Procedure: PKP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refraction
Refractive measured by Diopter
Measured: 1 year
Visual acuity
The decimal snellens
Measured: 1 year
Intra-ocular pressure
mg
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Jul 2018
- Primary completion1 Jun 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective non-comparative non-randomized clinical study which was conducted on 12 eyes of 8 patients 4 males and 4 females who underwent PKP for keratoconus, and then toric ICL was implanted after minimum of one year with stable refraction
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ehab Mossallam, PhD, Principal investigator, Alexandria Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457063
- Sponsor's protocol ID
- 0304624
- Status last verified
- Jun 2020
- First submitted
- 26 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Cell Loss Following Toric ICL Implantation for Correction of Myopia and Astigmatism After Penetrating Keratoplasty
- ClinicalTrials.gov ID
- NCT04457063
- Acronym / sponsor ID
- 0304624
- Conditions
- Keratoconus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 7 Jul 2020 (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.
This work aimed at the assessment of corneal endothelial cell loss after toric ICL implantation for correction of myopia and astigmatism after penetrating keratoplasty.
Detailed description
Penetrating keratoplasty (PKP) is considered a safe and effective procedure.This work aimed at the assessment of corneal endothelial cell loss after toric ICL implantation for correction of myopia and astigmatism after penetrating keratoplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective non-comparative non-randomized clinical study which was conducted on 12 eyes of 8 patients 4 males and 4 females who underwent PKP for keratoconus, and then toric ICL was implanted after minimum of one year with stable refraction
| Arm | Type | Receives |
|---|---|---|
| penetrating keratoplasty | Experimental | Procedure: PKPA prospective non-comparative non-randomized clinical study which was conducted on 12 eyes of 8 patients 4 males and 4 females who underwent PKP for keratoconus, and then toric ICL was implanted after minimum of one year with stable refraction |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- PKP for keratoconus, and then toric ICL was implanted after minimum of one year with stable refraction
Key exclusion criteria (1 listed)
- Less than 18 and unable to give informed consent
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 |
|---|---|---|
| PKP1. The horizontal axis was marked with a pointed marker at the slit lamp immediately before surgery. 2. TICL loading into the STAAR injector cartridge 3. Temporal clear corneal 3 mm incision \& 2-side ports then viscoelastic injection into the AC 4. Implantation of the TICL using the injector, then rotation according to the implantation diagram guided with Mendez protractor, and lastly placement of the haptics under the iris. 5. Pupil constriction with A.Ch. 6. Washing the viscoelastic \&Wound hydration. 7. Topical antibiotic steroids (Vigamox and Tobradex) 4 times /day for 3weeks | Procedure or surgery | penetrating keratoplasty |
Primary outcome
Refraction
Time frame: 1 year
Refractive measured by Diopter
Visual acuity
Time frame: 1 year
The decimal snellens
Intra-ocular pressure
Time frame: 1 year
mg
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Keratoconus
RecruitingObservational study
UNITY DX Cornea Study
Tomography
Not yet recruiting
Performance Evaluation of the OCUTOP Hand-held Corneal Topographer
Corneal Topography, Dry Eye Syndromes
Recruiting
Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus
Keratoconus, Presbyopia
RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Keratoconus, Ectasia
Enrolling by invitationObservational study
Corneal Biomechanical Analysis Using Brillouin Microscopy
Keratoconus, Keratoconus, Unstable
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.
Ehab Mossallam, PhD principal investigator
Alexandria Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PKP in people with Keratoconus, run by Alexandria University at 1 site in Egypt.
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 1 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: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Refraction (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2020.