Herpes Simplex KeratitisNCT03217474
Femtosecond Laser-assisted Corneal Debridement for Herpes Simplex Keratitis
A study testing FLDEB, Ganciclovir (GCV) and Femtosecond laser in people with Herpes Simplex Keratitis, run by Chunxiao Wang at 1 site in China.
Trial summary
The purpose of the study is to learn if adding femtosecond laser-assisted corneal debridement to a standard therapy of oral ganciclovir can help shorten the healing time of herpes simplex epithelial keratitis (HSK). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Herpes Simplex Keratitis
- What is being tested?
- FLDEB, Ganciclovir (GCV) and Femtosecond laser
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2017to 30 Dec 2019
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 80 years old;
- Epithelial ulceration in a dendritic or geographic pattern, characteristic of infection with herpes simplex virus, and within 7 days of onset;
- Ulcer's stromal involvement < 120 micron, as indicated by anterior segment optical coherence tomography;
- Informed consent signed by patient or legal guardian. Having the ability to comply with study assessments for the full duration of the study.
Who cannot join
- Clinical signs of a cause other than herpes simplex virus for the epithelial keratitis;
- Antivirus or corticosteroid treatment within 6 months;
- Active stromal keratitis or iritis;
- History of allergy or adverse reaction to ganciclovir;
- High myopia with a spherical equivalent of -15.0 D or less;
- Corneal or ocular surface infection within 30 days prior to study entry;
Show all 20Show fewer
- Ocular surface malignancy;
- Uncontrolled diabetes with most recent Hemoglobin A1c greater than 8.5%;
- Renal failure with creatinine clearance< 25ml/min;
- Alanine aminotransferase > 40IU/L, or aspartate aminotransferase > 40IU/L;
- Platelet levels < 150,000 or > 450,000 per microliter;
- Hemoglobin < 12.0 g/dL (male) or < 11.0 g/dL (female);
- Prothrombin time > 16s and activated partial thrombin time > 35s in patients not accepting anticoagulant therapy; An international normalized ratio greater than 3 in patients accepting anticoagulant therapy;
- Pregnancy (positive test) or lactation;
- Participation in another simultaneous medical investigation or clinical trial;
- Severe cicatricial eye disease; Conjunctival scarring with fornix shortening;
- Severe dry eye disease as determined by Schirmer's test < 2mm at least in one eye;
- Any medical or social condition that in the judgement of the investigator would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent;
- Active immunological diseases;
- History of allo-limbal transplantation, penetrating keratoplasty or anti-glaucoma filtering surgeries.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
Guangzhou, Guangdong, 5
Yingfeng Zheng, M.D. Ph.D.
About this study
Official title: A Randomized Controlled Clinical Trial of Corneal Debridement for the Treatment of Herpes Simplex Epithelial Keratitis
The purpose of the study is to learn if adding femtosecond laser-assisted corneal debridement to a standard therapy of oral ganciclovir can help shorten the healing time of herpes simplex epithelial keratitis (HSK).
- Conditions
- Herpes Simplex Keratitis
- Being tested
- FLDEB, Ganciclovir (GCV), Femtosecond laser
- Medical subject headings
- Keratitis, Herpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLDEBProcedure or surgery
Also called Femtosecond laser-assisted corneal debridement
The eye will be anesthetized, and femtosecond laser technology will be used to remove epithelial tissue (diameter: 8mm; depth: 100micron) that includes the loosened diseased corneal epithelial cells. Antibiotic ointments and drops will be instilled postoperatively.
Ganciclovir (GCV)Drug
Patient will be treated with GCV orally (200mg, 3 times a day, for 14 days).
Femtosecond laserDevice
A commercial femtosecond laser to create a particular shaped graft for transplantation.
| Study group | Role | What they receive |
|---|---|---|
| FLDEB combined with GCV orally | Experimental | Femtosecond laser-assisted cornea debridement (FLDEB) combined with ganciclovir (GCV) orally. Receives: Procedure: FLDEB; Drug: Ganciclovir (GCV); Device: Femtosecond laser |
| GCV orally | Active comparator | Ganciclovir (GCV) orally only Receives: Drug: Ganciclovir (GCV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing time
Time to complete corneal epithelial healing
Measured: 14 ± 1 days
Secondary outcomes (6)
Corneal re-epithelization
Assessing complete corneal re-epithelization at day 14±1 using slit-lamp microcopy
Measured: 14 ± 1 days
Corneal opacity and vascularization
Assessing corneal opacity and vascularization using slit-lamp microcopy
Measured: Baseline, 14 ± 1 days, 3 months
Best-corrected visual acuity
Assessing best-corrected visual acuity using ETDRS chart
Measured: Baseline, 14 ± 1 days, 3 months
Corneal power and astigmatism
Assessing changes of corneal power and astigmatism using autorefractor keratometer
Measured: Baseline, 14 ± 1 days, 3 months
Corneal sensation
Assessing corneal sensation using Cochet-Bonnet esthesiometer
Measured: Baseline, 14 ± 1 days, 3 months
Recurrence
Assessing recurrent HSK using slit-lamp microcopy
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start20 Jul 2017
- Primary completion30 Dec 2018 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes Simplex KeratitisStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chunxiao Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chunxiao Wang, Sun Yat-sen University
- Investigators
- Yizhi Liu, M.D.Ph.D., Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityTing Huang, M.D.Ph.D., Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217474
- Sponsor's protocol ID
- 2017KYPJ052
- Status last verified
- Feb 2018
- First submitted
- 12 Jul 2017
- Last updated
- 22 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial of Corneal Debridement for the Treatment of Herpes Simplex Epithelial Keratitis
- ClinicalTrials.gov ID
- NCT03217474
- Acronym / sponsor ID
- 2017KYPJ052
- Conditions
- Herpes Simplex Keratitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chunxiao WangUniversity, hospital or other
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 14 Jul 2017 (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.
The purpose of the study is to learn if adding femtosecond laser-assisted corneal debridement to a standard therapy of oral ganciclovir can help shorten the healing time of herpes simplex epithelial keratitis (HSK).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FLDEB combined with GCV orally | Experimental | Procedure: FLDEB, Drug: Ganciclovir (GCV), Device: Femtosecond laserFemtosecond laser-assisted cornea debridement (FLDEB) combined with ganciclovir (GCV) orally. |
| GCV orally | Active comparator | Drug: Ganciclovir (GCV)Ganciclovir (GCV) orally only |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 18 and 80 years old;
- Epithelial ulceration in a dendritic or geographic pattern, characteristic of infection with herpes simplex virus, and within 7 days of onset;
- Ulcer's stromal involvement < 120 micron, as indicated by anterior segment optical coherence tomography;
- Informed consent signed by patient or legal guardian. Having the ability to comply with study assessments for the full duration of the study.
Key exclusion criteria (20 listed)
- Clinical signs of a cause other than herpes simplex virus for the epithelial keratitis;
- Antivirus or corticosteroid treatment within 6 months;
- Active stromal keratitis or iritis;
- History of allergy or adverse reaction to ganciclovir;
- High myopia with a spherical equivalent of -15.0 D or less;
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 |
|---|---|---|
| FLDEBAlso: Femtosecond laser-assisted corneal debridementThe eye will be anesthetized, and femtosecond laser technology will be used to remove epithelial tissue (diameter: 8mm; depth: 100micron) that includes the loosened diseased corneal epithelial cells. Antibiotic ointments and drops will be instilled postoperatively. | Procedure or surgery | FLDEB combined with GCV orally |
| Ganciclovir (GCV)Patient will be treated with GCV orally (200mg, 3 times a day, for 14 days). | Drug | FLDEB combined with GCV orally, GCV orally |
| Femtosecond laserA commercial femtosecond laser to create a particular shaped graft for transplantation. | Device | FLDEB combined with GCV orally |
Primary outcome
Healing time
Time frame: 14 ± 1 days
Time to complete corneal epithelial healing
6 secondary outcomes
Corneal re-epithelization
Time frame: 14 ± 1 days
Corneal opacity and vascularization
Time frame: Baseline, 14 ± 1 days, 3 months
Best-corrected visual acuity
Time frame: Baseline, 14 ± 1 days, 3 months
Corneal power and astigmatism
Time frame: Baseline, 14 ± 1 days, 3 months
Corneal sensation
Time frame: Baseline, 14 ± 1 days, 3 months
Recurrence
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
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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.
Yizhi Liu, M.D.Ph.D. principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
Ting Huang, M.D.Ph.D. principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLDEB, Ganciclovir (GCV) and Femtosecond laser in people with Herpes Simplex Keratitis, run by Chunxiao Wang at 1 site in China.
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 4 inclusion and 20 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 22 Feb 2018. 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 China. 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 Yingfeng Zheng, M.D.Ph.D. (+8613922286455, yingfeng.zheng@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing time (time frame: 14 ± 1 days). 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 22 Feb 2018.