Photorefractive KeratectomyNCT05313425
Effect of Ectoine After Photorefractive Keratectomy (PRK).
An observational study of Photorefractive Keratectomy and Corneal Haze, run by Tanta University at 1 site in Egypt.
Trial summary
This is a comparative, open label, parallel group, non interventional study aims to assess the effect of Ectoine containing eye drops on stromal haze, pain and epithelial healing after Photorefractive keratectomy (PRK). Read more about this study
- Who is it for?
- Ages 19 to 35 years
- Conditions the study is for
- Photorefractive Keratectomy, Corneal Haze
- What is being tested?
- Ectohylo (R) eye drops
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to Oct 2022
- 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 19 to 35 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patient enrolled for photorefractive keratectomy for correction of myopia and myopic astigmatism.
Who may be able to join
- Patient undergoing PRK for myopia and myopic astigmatism when astigmatism is 2.5 diopters or less and myopia with spherical equivalent -4 or less.
Who cannot join
- patient spherical equivalent more myopic than -4 diopters
- Patients with astigmatism more than 2.5 diopter
- Patients with anisometropia ( difference > 2 diopters)
- Patient with previous ocular surgery
- Patients with chronic systemic disease that can affect results of laser vision correction (e.g. rheumatoid arthritis)
- Pregnant and lactating females
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El Gharbia, 31512
Mohamed Elkadim, 01004991183, mzekadem@gmail.com
About this study
Official title: Effect of Ectoine on Stromal Haze, Wound Healing and Pain After Photorefractive Keratectomy.
This is a comparative, open label, parallel group, non interventional study aims to assess the effect of Ectoine containing eye drops on stromal haze, pain and epithelial healing after Photorefractive keratectomy (PRK). The patient apply Ectohylo eye drops (Ectoine +Sodium Hyauronate) in the right eye and Polyfresh Extra eye drops (Carboxymethyl cellulose + Sodium Hyauronate ) in the left eye plus the routine post PRK treatment in both eyes. Post operative pain , epithelial healing and corneal densitometry is observed in both eyes.
Read the detailed description
Photorefractive keratectomy (PRK) is a commonly used operation for laser vision correction. The main fears of this type of laser vision correction is corneal haze, delayed epithelial healing and postoperative severe pain. Ectoine is a natural compound that has the ability to protect biological membranes from damage and environmental effects. This study assess the use of Ectoine containing eye drops to protect the bare ocular surface and reduce inflammation after PRK that will inturn is expected to affect the post operative corneal haze, pain, and epithelial healing .
- Conditions
- Photorefractive Keratectomy, Corneal Haze
- Being tested
- Ectohylo (R) eye drops
- Keywords
- PRK, surface ablation, corneal haze
- Medical subject headings
- Corneal Opacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ectohylo (R) eye dropsOther
Also called Ectoine 2% eye drops
using Ectohylo eye drops post operative after PRK in the right eyes of the patients
| Study group | Role | What they receive |
|---|---|---|
| Ectoine Eye | The right eye of the studied group will be given 2% Ectoine containig , 0.2% sodium hyaluronate eye drops(Ectohylo) hourly. Receives: Other: Ectohylo (R) eye drops | |
| Control eye | The left eye of the studied group will be give Carboxymethyl cellulose, 0.2% sodium hyaluronate eye drops(Polyfresh Extra) hourly. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Densitometry (assesed by Pentacam).
Post photo refractive keratectomy early haze (3 months after operation) assesed by Pentacam densitometry
Measured: 3 months post operative
Secondary outcomes (2)
Pain score (0 -10)
pain in the first 2 days post operative (graded 0 to 10)
Measured: 2 days
Time of Epithelial healing (days)
Time required for epithelial healing after PRK in days
Measured: 2-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start1 Jan 2022
- Primary completionMay 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photorefractive KeratectomyStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elkadim, Tanta University
- Investigators
- Mohamed Elkadim, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313425
- Sponsor's protocol ID
- Ectoine after PRK
- Status last verified
- Mar 2022
- First submitted
- 29 Mar 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in Cornea. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ectoine on Stromal Haze, Wound Healing and Pain After Photorefractive Keratectomy.
- ClinicalTrials.gov ID
- NCT05313425
- Acronym / sponsor ID
- Ectoine after PRK
- Conditions
- Photorefractive Keratectomy, Corneal Haze
- Keywords
- PRK, surface ablation, corneal haze
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 6 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.
This is a comparative, open label, parallel group, non interventional study aims to assess the effect of Ectoine containing eye drops on stromal haze, pain and epithelial healing after Photorefractive keratectomy (PRK). The patient apply Ectohylo eye drops (Ectoine +Sodium Hyauronate) in the right eye and Polyfresh Extra eye drops (Carboxymethyl cellulose + Sodium Hyauronate ) in the left eye plus the routine post PRK treatment in both eyes. Post operative pain , epithelial healing and corneal densitometry is observed in both eyes.
Detailed description
Photorefractive keratectomy (PRK) is a commonly used operation for laser vision correction. The main fears of this type of laser vision correction is corneal haze, delayed epithelial healing and postoperative severe pain. Ectoine is a natural compound that has the ability to protect biological membranes from damage and environmental effects. This study assess the use of Ectoine containing eye drops to protect the bare ocular surface and reduce inflammation after PRK that will inturn is expected to affect the post operative corneal haze, pain, and epithelial healing .
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ectoine Eye | – | Other: Ectohylo (R) eye dropsThe right eye of the studied group will be given 2% Ectoine containig , 0.2% sodium hyaluronate eye drops(Ectohylo) hourly. |
| Control eye | – | –The left eye of the studied group will be give Carboxymethyl cellulose, 0.2% sodium hyaluronate eye drops(Polyfresh Extra) hourly. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patient enrolled for photorefractive keratectomy for correction of myopia and myopic astigmatism.
Key inclusion criteria (1 listed)
- Patient undergoing PRK for myopia and myopic astigmatism when astigmatism is 2.5 diopters or less and myopia with spherical equivalent -4 or less.
Key exclusion criteria (6 listed)
- patient spherical equivalent more myopic than -4 diopters
- Patients with astigmatism more than 2.5 diopter
- Patients with anisometropia ( difference > 2 diopters)
- Patient with previous ocular surgery
- Patients with chronic systemic disease that can affect results of laser vision correction (e.g. rheumatoid arthritis)
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 |
|---|---|---|
| Ectohylo (R) eye dropsAlso: Ectoine 2% eye dropsusing Ectohylo eye drops post operative after PRK in the right eyes of the patients | Other | Ectoine Eye |
Primary outcome
Corneal Densitometry (assesed by Pentacam).
Time frame: 3 months post operative
Post photo refractive keratectomy early haze (3 months after operation) assesed by Pentacam densitometry
2 secondary outcomes
Pain score (0 -10)
Time frame: 2 days
Time of Epithelial healing (days)
Time frame: 2-7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in Cornea. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party
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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.
Mohamed Elkadim principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Photorefractive Keratectomy and Corneal Haze, run by Tanta 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 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 6 Apr 2022. 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 Mohamed Elkadim, MD (01004991183, mzekadem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal Densitometry (assesed by Pentacam). (time frame: 3 months post operative). 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 6 Apr 2022.