KeratoconusNCT05055349
Intrastromal Corneal Ring Segments and Toric Phakic Posterior Intra-ocular Lenses Implantation in Keratoconus
A study testing corneal ring segments in people with Keratoconus, run by Minia University at 1 site in Egypt.
Trial summary
To compare visual and refractive measurements of intrastromal corneal ring segments versus toric phakic posterior intra-ocular lenses implantation in keratoconus Read more about this study
- Who is it for?
- Ages 21 to 40 years
- Conditions the study is for
- Keratoconus
- What is being tested?
- corneal ring segments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Nov 2019to 22 Nov 2021
- Phase
- Interventional
- 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 21 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Keratoconus grade I to III according to the Amsler-Krumeich classification
Who cannot join
- Acute hydrops or grade IV keratoconus
- Any ocular diseases or surgeries
- Corneal thickness less than 400 µm at the thinnest corneal point, and at least 450 µm at the incision site for ICRS group
- Corneal pacities
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Maher Khalafallah
Minya
ahmed maher khalafallah, 01119094426, drahmedmaher1988@gmail.com
About this study
Official title: "Comparison Between Intrastromal Corneal Ring Segments and Toric Phakic Posterior Intra-ocular Lenses Implantation in Keratoconus"
To compare visual and refractive measurements of intrastromal corneal ring segments versus toric phakic posterior intra-ocular lenses implantation in keratoconus
Read the detailed description
- The study is a prospective comparative interventional case series. It will be conducted in Minia university hospital and Roaa Laser Vision Correction Center.
- Fourty eyes will be evenly allocated into two groups:
Group (A): 20 eyes will undergo corneal collagen cross linking (epithelium off) 1 month after Femtosecond laser assisted intrastromal corneal keraring segments.
Group (B): 20 eyes will undergo toric phakic posterior IOL implantation 1 year after corneal collagen cross linking (epithelium off).
- An informed written consent to be involved in the study will be obtained from each patient.
- Conditions
- Keratoconus
- Being tested
- corneal ring segments
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corneal ring segmentsOther
Also called toric phakic posterior IOL implantation/ corneal collagen cross linking
ring hard segments inserted within corneal stroma using femtolaser
| Study group | Role | What they receive |
|---|---|---|
| corneal collagen cross linking and intrastromal corneal keraring segments. | Active comparator | 20 eyes will undergo corneal collagen cross linking (epithelium off) 1 month after Femtosecond laser assisted intrastromal corneal keraring segments Receives: Other: corneal ring segments |
| toric phakic posterior IOL implantation and corneal collagen cross linking | Active comparator | 20 eyes will undergo toric phakic posterior IOL implantation 1 year after corneal collagen cross linking (epithelium off). Receives: Other: corneal ring segments |
What is being measured
The primary outcome is the main question the study is designed to answer.
pentacam readings
a device that read topometric corneal data and other data
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start28 Nov 2019
- Primary completion15 Nov 2021 (estimated)
- Study completion22 Nov 2021 (estimated)
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 Minia 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maher Khalafallah, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055349
- Sponsor's protocol ID
- 324 : 11/2019
- Status last verified
- Sep 2021
- First submitted
- 25 Mar 2021
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Comparison Between Intrastromal Corneal Ring Segments and Toric Phakic Posterior Intra-ocular Lenses Implantation in Keratoconus"
- ClinicalTrials.gov ID
- NCT05055349
- Acronym / sponsor ID
- 324 : 11/2019
- Conditions
- Keratoconus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 28 Nov 2019 (actual)
- Primary completion
- 15 Nov 2021 (estimated)
- Study completion
- 22 Nov 2021 (estimated)
- First posted
- 24 Sep 2021 (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.
To compare visual and refractive measurements of intrastromal corneal ring segments versus toric phakic posterior intra-ocular lenses implantation in keratoconus
Detailed description
- The study is a prospective comparative interventional case series. It will be conducted in Minia university hospital and Roaa Laser Vision Correction Center.
- Fourty eyes will be evenly allocated into two groups:
Group (A): 20 eyes will undergo corneal collagen cross linking (epithelium off) 1 month after Femtosecond laser assisted intrastromal corneal keraring segments.
Group (B): 20 eyes will undergo toric phakic posterior IOL implantation 1 year after corneal collagen cross linking (epithelium off).
- An informed written consent to be involved in the study will be obtained from each patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| corneal collagen cross linking and intrastromal corneal keraring segments. | Active comparator | Other: corneal ring segments20 eyes will undergo corneal collagen cross linking (epithelium off) 1 month after Femtosecond laser assisted intrastromal corneal keraring segments |
| toric phakic posterior IOL implantation and corneal collagen cross linking | Active comparator | Other: corneal ring segments20 eyes will undergo toric phakic posterior IOL implantation 1 year after corneal collagen cross linking (epithelium off). |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Keratoconus grade I to III according to the Amsler-Krumeich classification
Key exclusion criteria (4 listed)
- Acute hydrops or grade IV keratoconus
- Any ocular diseases or surgeries
- Corneal thickness less than 400 µm at the thinnest corneal point, and at least 450 µm at the incision site for ICRS group
- Corneal pacities
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 |
|---|---|---|
| corneal ring segmentsAlso: toric phakic posterior IOL implantation/ corneal collagen cross linkingring hard segments inserted within corneal stroma using femtolaser | Other | corneal collagen cross linking and intrastromal corneal keraring segments., toric phakic posterior IOL implantation and corneal collagen cross linking |
Primary outcome
pentacam readings
Time frame: 1 month
a device that read topometric corneal data and other data
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing corneal ring segments in people with Keratoconus, run by Minia 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 4 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 24 Sep 2021. 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.
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 ahmed maher khalafallah (01119094426, drahmedmaher1988@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pentacam readings (time frame: 1 month). 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 24 Sep 2021.