Dry Eye After LASIK-Laser in Situ KeratomileusisPhase 2PRP-OSSNCT03322917
Ocular Surface Syndrome Post-lasik, Outcomes of Treatment With Platelet Rich Plasma
A Phase 2 study testing PRP autologous in people with Dry Eye After LASIK-Laser in Situ Keratomileusis, run by Vissum, Instituto Oftalmológico de Alicante.
Trial summary
To evaluate the efficacy of autologous platelet-rich plasma eye drops (E-PRP) for the treatment of chronic ocular surface syndrome (OSS) following laser in situ keratomileusis (LASIK). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Dry Eye After LASIK-Laser in Situ Keratomileusis
- What is being tested?
- PRP autologous
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2008to 17 Jan 2013
- Phase
- Phase 2
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients suffering from moderate to severe dry eye syndrome for 6 months or more after conventional treatments with artificial tears following LASIK.
- Tear break-up time (TBUT) between 4 and 9 seconds.
Who cannot join
- Ocular pathology needing topical treatments different than dry eye syndrome
- Trombocitopeny, associated pathologies to coagulation factors or any state of plaquets antiagregation (AAS and other AINES).
- Ocular tumours, corneal distrophies, history of ocular herpes.
- Pregnant or nursering women.
About this study
Official title: A Prospective Interventional Non-randomized and Non-comparative Series of Cases of Patiens Suffering Ocular Surface Syndrome Post-LASIK: Outcomes After the Treatment With Platelet Rich Plasma
To evaluate the efficacy of autologous platelet-rich plasma eye drops (E-PRP) for the treatment of chronic ocular surface syndrome (OSS) following laser in situ keratomileusis (LASIK).
Read the detailed description
Prospective interventional consecutive case series including 156 eyes of 80 patients affected by chronic post-LASIK OSS who were treated with autologous E-PRP 6 times a day as monotherapy for 6 weeks. Assessment after treatment with E-PRP included: dry eye symptoms, change in corrected distance visual acuity (CDVA), corneal fluorescein staining (CFS) and conjunctival hyperemia.
- Being tested
- PRP autologous
- Keywords
- dry eye, PRP, autologous, after LASIK, ocular surface
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP autologousBiological
Autologous platelet rich plasma: 1 drop / 6 times a day during 6 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal fluorescein staining (CFS)
Staining using fluorescein will be graded using the modified Oxford scale (7-point ordinal scale, score 0, 0.5, and 1 to 5 (see Appendix 2). On this modified scale, the score 0 corresponds to no staining dots and the score 0.5 to three or less staining dots. A CFS grade of 0 represents complete corneal clearing.
A negative change from baseline will indicate improvement.
Measured: Before LASIK surgery and after the 6 weeks of treatment
Secondary outcomes (3)
Dry eye symptoms
The symptoms of ocular discomfort (unrelated to instillation of the study medication), burning/stinging, foreign body sensation, eye dryness, pain, will be assessed for intensity by the study patients using a self-administered VAS ranging from 0% to 100%. The symptoms will be assessed separately for each eye and data from the worst eye will be used for analysis.
A decrease in the VAS score from baseline will indicate improvement.
Measured: Before LASIK surgery and after the 6 weeks of treatment
Corrected distance visual acuity (CDVA)
Best corrected distance visual acuity (BCDVA) will be measured using the LogMar scale. The patient is seated at 3 or 4 m from the EDTRS or modified EDTRS chart, depending on chart size and must try to read all letters first while covering the left eye, then while covering the right eye.
Measured: Before LASIK surgery and after the 6 weeks of treatment
Conjunctival hyperemia
Biomicroscopy will be performed using a slit lamp. The patient will be seated while being examined grading of the conjunctival hyperemia, according to the following scales:
0 = None (normal).
- = Mild (a flush reddish color predominantly confined to the palpebral or bulbar conjunctiva).
- = Moderate (more prominent red color of the palpebral or bulbar conjunctiva).
- = Severe (definite redness of palpebral or bulbar conjunctiva).
Measured: Before LASIK surgery and after the 6 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start1 Jul 2008
- Primary completion17 Jan 2013
- Study completion17 Jan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry Eye After LASIK-Laser in Situ KeratomileusisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective interventional non-comparative consecutive case series.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vissum, Instituto Oftalmológico de Alicante
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JORGE L ALIO, DR., Principal investigator, Vissum, Instituto Oftalmológico de Alicante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322917
- Sponsor's protocol ID
- PRP-autologous/0208
- Acronym
- PRP-OSS
- Status last verified
- Dec 2017
- First submitted
- 18 Oct 2017
- Last updated
- 4 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alio JL, Rodriguez AE, Abdelghany AA, Oliveira RF. Autologous Platelet-Rich Plasma Eye Drops for the Treatment of Post-LASIK Chronic Ocular Surface Syndrome. J Ophthalmol. 2017;2017:2457620. doi: 10.1155/2017/2457620. Epub 2017 Dec 12.
PubMed 29379652
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Interventional Non-randomized and Non-comparative Series of Cases of Patiens Suffering Ocular Surface Syndrome Post-LASIK: Outcomes After the Treatment With Platelet Rich Plasma
- ClinicalTrials.gov ID
- NCT03322917
- Acronym / sponsor ID
- PRP-OSS / PRP-autologous/0208
- Keywords
- dry eye, PRP, autologous, after LASIK, ocular surface
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Vissum, Instituto Oftalmológico de AlicanteUniversity, hospital or other
- Study start
- 1 Jul 2008 (actual)
- Primary completion
- 17 Jan 2013 (actual)
- Study completion
- 17 Jan 2013 (actual)
- First posted
- 26 Oct 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.
To evaluate the efficacy of autologous platelet-rich plasma eye drops (E-PRP) for the treatment of chronic ocular surface syndrome (OSS) following laser in situ keratomileusis (LASIK).
Detailed description
Prospective interventional consecutive case series including 156 eyes of 80 patients affected by chronic post-LASIK OSS who were treated with autologous E-PRP 6 times a day as monotherapy for 6 weeks. Assessment after treatment with E-PRP included: dry eye symptoms, change in corrected distance visual acuity (CDVA), corneal fluorescein staining (CFS) and conjunctival hyperemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Prospective interventional non-comparative consecutive case series.
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients suffering from moderate to severe dry eye syndrome for 6 months or more after conventional treatments with artificial tears following LASIK.
- Tear break-up time (TBUT) between 4 and 9 seconds.
Key exclusion criteria (4 listed)
- Ocular pathology needing topical treatments different than dry eye syndrome
- Trombocitopeny, associated pathologies to coagulation factors or any state of plaquets antiagregation (AAS and other AINES).
- Ocular tumours, corneal distrophies, history of ocular herpes.
- Pregnant or nursering women.
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 |
|---|---|---|
| PRP autologousAutologous platelet rich plasma: 1 drop / 6 times a day during 6 weeks | Biological | – |
Primary outcome
Corneal fluorescein staining (CFS)
Time frame: Before LASIK surgery and after the 6 weeks of treatment
Staining using fluorescein will be graded using the modified Oxford scale (7-point ordinal scale, score 0, 0.5, and 1 to 5 (see Appendix 2). On this modified scale, the score 0 corresponds to no staining dots and the score 0.5 to three or less staining dots. A CFS grade of 0 represents complete corneal clearing. A negative change from baseline will indicate improvement.
3 secondary outcomes
Dry eye symptoms
Time frame: Before LASIK surgery and after the 6 weeks of treatment
Corrected distance visual acuity (CDVA)
Time frame: Before LASIK surgery and after the 6 weeks of treatment
Conjunctival hyperemia
Time frame: Before LASIK surgery and after the 6 weeks of treatment
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 4 Dec 2017.
- Derived from this study: PubMed 29379652Alio JL, Rodriguez AE, Abdelghany AA, Oliveira RF. Autologous Platelet-Rich Plasma Eye Drops for the Treatment of Post-LASIK Chronic Ocular Surface Syndrome. J Ophthalmol. 2017;2017:2457620. doi: 10.1155/2017/2457620. Epub 2017 Dec 12.
- Individual participant dataSharing planned: No
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.
JORGE L ALIO, DR. principal investigator
Vissum, Instituto Oftalmológico de Alicante
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRP autologous in people with Dry Eye After LASIK-Laser in Situ Keratomileusis, run by Vissum, Instituto Oftalmológico de Alicante.
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 2 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: finished, as of the sponsor's last update on 4 Dec 2017. 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.
What does this 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.
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?
Corneal fluorescein staining (CFS) (time frame: Before LASIK surgery and after the 6 weeks of treatment). 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 NCT03322917, which also lists 1 linked publication.
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 4 Dec 2017.