HyperopiaNCT02316041
Clinical Trial of the Femtosecond Laser System VisuMax for Refractive Correction of Hyperopia by Means of Lenticule Extraction
A study testing Small incision lenticule extraction and ReLEx® (SMILE) in people with Hyperopia, run by Tilganga Institute of Ophthalmology at 1 site in Nepal.
Trial summary
This is a feasibility and clinical evaluation study of the VisuMax femtosecond laser for refractive correction of hyperopia using the small incision lenticule extraction (ReLEx smile) method. In ReLEx® the VisuMax femtosecond laser creates two interfaces that define a refractive lenticule of stromal tissue. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperopia
- What is being tested?
- Small incision lenticule extraction and ReLEx® (SMILE)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteNepal
- Study dates
- Jan 2014to Dec 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- older than 21 years of age,
- maximum hyperopic meridian between +1.00D and +7.00D
- astigmatism up to 6D
- CDVA of:
- 20/200 or worse in the eye(s) being treated for Phase I
- Between 20/200 and 20/100 in the eye(s) being treated for Phase II
Show all 15Show fewer
- Between 20/40 and 20/60 in the eye(s) being treated for Phase III
- 20/25 or better for Phase IV
- total uncut stromal thickness of more than 300 µm
- no previous refractive surgery,
- no ocular disease,
- normal corneal topography,
- contact lens wearers have to stop wearing hard contact lenses at least 4 weeks and soft contact lenses 2 weeks prior to pre-examination,
- willing to attend follow-up examinations within the scope of the clinical investigation,
- able and willing to sign the informed consent
Who cannot join
- patients who are not being able to lie flat in a horizontal position,
- patients who are not being able to understand and give informed consent,
- pregnant or nursing women (or women who are planning to became pregnant during the clinical investigation),
- diagnosis of an autoimmune disease (e.g. AIDS), connective tissue disease or diabetes,
- treatment with medications such as steroids or immune-suppressants,
- herpes simplex or herpes zoster keratitis,
- all standard medical exclusion criteria for LASIK
Trial locations and contacts
1 site in 1 country.
Govinda Ojha contact
Nepal1 site, 1 recruiting
- Recruiting
Tilganga Institute of Ophthalmology, Refractive Surgery Unit
Kathmandu
Govinda Ojha, ojhagovinda@hotmail.com
About this study
This is a feasibility and clinical evaluation study of the VisuMax femtosecond laser for refractive correction of hyperopia using the small incision lenticule extraction (ReLEx smile) method.
In ReLEx® the VisuMax femtosecond laser creates two interfaces that define a refractive lenticule of stromal tissue. In ReLEx® FLEx, the upper interface is converted into a LASIK flap by the creation of a sidecut. The LASIK flap is lifted and the lenticule can be removed to correct the refractive error by tissue subtraction. In ReLEx® smile, the lenticule is dissected and removed through a small 2-3mm incision without the need to create a whole flap.
The aims are i) to optimize the VisuMax settings for lenticule separation ii) to optimize the lenticule geometry iii) to assess the safety, efficacy and stability of the treatment
- Conditions
- Hyperopia
- Being tested
- Small incision lenticule extraction, ReLEx® (SMILE)
- Keywords
- Femtosecond laser, Small incision lenticule extraction (SMILE)
- Medical subject headings
- Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small incision lenticule extractionProcedure or surgery
Also called SMILE, Refractive lenticule extraction, ReLEx
The VisuMax femtosecond laser is used to create two interfaces that define a refractive lenticule of stromal tissue and a 2mm wide tunnel to connect the upper layer to the corneal surface. The lenticule is manually dissected and removed through the small 2mm incision without the need to create a flap as in LASIK.
ReLEx® (SMILE)Device
| Study group | Role | What they receive |
|---|---|---|
| Small incision lenticule extraction | Experimental | Small incision lenticule extraction (SMILE) is a form of corneal laser refractive surgery performed using a femtosecond laser Receives: Procedure: Small incision lenticule extraction; Device: ReLEx® (SMILE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of corrected distance visual acuity (change in corrected distance visual acuity)
Assess the change in corrected distance visual acuity (CDVA) before and after the SMILE procedure.
Measured: 1 year
Efficacy of uncorrected distance visual acuity (uncorrected distance visual acuity achieved after the SMILE procedure relative to the preoperative CDVA)
Measure the uncorrected distance visual acuity achieved after the SMILE procedure relative to the preoperative CDVA for all eyes where the intended target refraction was emmetropia.
Measured: 1 year
Predictability of refractive outcome ( change in manifest refractive error)
Measure the change in manifest refractive error (sphere, cylinder, spherical equivalent) after the SMILE procedure and analyze the predictability relative to the intended target refraction as well as the refractive stability over the 1 year follow-up period
Measured: 1 year
Secondary outcomes (2)
Optical zone centration (Measure the achieved centration of the optical zone)
Measure the achieved centration of the optical zone by topography relative to the corneal vertex (the intended treatment center)
Measured: 1 year
Optical zone diameter
Measure the achieved optical zone diameter from tangential curvature difference maps relative to the intended optical zone
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 posted12 Dec 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2018 (estimated)
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 HyperopiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tilganga Institute of Ophthalmology
- Sponsor type
- University, hospital or other
- Collaborators
- London Vision Clinic
- Responsible party
- Sponsor
- Investigators
- Kishore R Pradhan, MD, Principal investigator, Tilganga Institute of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316041
- Sponsor's protocol ID
- 177/2013
- Status last verified
- Apr 2018
- First submitted
- 9 Dec 2014
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Blum M, Kunert KS, Vossmerbaumer U, Sekundo W. Femtosecond lenticule extraction (ReLEx) for correction of hyperopia - first results. Graefes Arch Clin Exp Ophthalmol. 2013 Jan;251(1):349-55. doi: 10.1007/s00417-012-2064-y. Epub 2012 Jun 14.
PubMed 22695934
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of the Femtosecond Laser System VisuMax for Refractive Correction of Hyperopia by Means of Lenticule Extraction
- ClinicalTrials.gov ID
- NCT02316041
- Acronym / sponsor ID
- 177/2013
- Conditions
- Hyperopia
- Keywords
- Femtosecond laser, Small incision lenticule extraction (SMILE)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Tilganga Institute of OphthalmologyUniversity, hospital or other
- Collaborators
- London Vision Clinic
- Study start
- Jan 2014
- Primary completion
- Dec 2018 (estimated)
- First posted
- 12 Dec 2014 (estimated)
- 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 feasibility and clinical evaluation study of the VisuMax femtosecond laser for refractive correction of hyperopia using the small incision lenticule extraction (ReLEx smile) method.
In ReLEx® the VisuMax femtosecond laser creates two interfaces that define a refractive lenticule of stromal tissue. In ReLEx® FLEx, the upper interface is converted into a LASIK flap by the creation of a sidecut. The LASIK flap is lifted and the lenticule can be removed to correct the refractive error by tissue subtraction. In ReLEx® smile, the lenticule is dissected and removed through a small 2-3mm incision without the need to create a whole flap.
The aims are i) to optimize the VisuMax settings for lenticule separation ii) to optimize the lenticule geometry iii) to assess the safety, efficacy and stability of the treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Small incision lenticule extraction | Experimental | Procedure: Small incision lenticule extraction, Device: ReLEx® (SMILE)Small incision lenticule extraction (SMILE) is a form of corneal laser refractive surgery performed using a femtosecond laser |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- older than 21 years of age,
- maximum hyperopic meridian between +1.00D and +7.00D
- astigmatism up to 6D
- CDVA of:
- total uncut stromal thickness of more than 300 µm
Key exclusion criteria (7 listed)
- patients who are not being able to lie flat in a horizontal position,
- patients who are not being able to understand and give informed consent,
- pregnant or nursing women (or women who are planning to became pregnant during the clinical investigation),
- diagnosis of an autoimmune disease (e.g. AIDS), connective tissue disease or diabetes,
- treatment with medications such as steroids or immune-suppressants,
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 |
|---|---|---|
| Small incision lenticule extractionAlso: SMILE, Refractive lenticule extraction, ReLExThe VisuMax femtosecond laser is used to create two interfaces that define a refractive lenticule of stromal tissue and a 2mm wide tunnel to connect the upper layer to the corneal surface. The lenticule is manually dissected and removed through the small 2mm incision without the need to create a flap as in LASIK. | Procedure or surgery | Small incision lenticule extraction |
| ReLEx® (SMILE) | Device | Small incision lenticule extraction |
Primary outcome
Safety of corrected distance visual acuity (change in corrected distance visual acuity)
Time frame: 1 year
Assess the change in corrected distance visual acuity (CDVA) before and after the SMILE procedure.
Efficacy of uncorrected distance visual acuity (uncorrected distance visual acuity achieved after the SMILE procedure relative to the preoperative CDVA)
Time frame: 1 year
Measure the uncorrected distance visual acuity achieved after the SMILE procedure relative to the preoperative CDVA for all eyes where the intended target refraction was emmetropia.
Predictability of refractive outcome ( change in manifest refractive error)
Time frame: 1 year
Measure the change in manifest refractive error (sphere, cylinder, spherical equivalent) after the SMILE procedure and analyze the predictability relative to the intended target refraction as well as the refractive stability over the 1 year follow-up period
2 secondary outcomes
Optical zone centration (Measure the achieved centration of the optical zone)
Time frame: 1 year
Optical zone diameter
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2018.
- Background: PubMed 22695934Blum M, Kunert KS, Vossmerbaumer U, Sekundo W. Femtosecond lenticule extraction (ReLEx) for correction of hyperopia - first results. Graefes Arch Clin Exp Ophthalmol. 2013 Jan;251(1):349-55. doi: 10.1007/s00417-012-2064-y. Epub 2012 Jun 14.
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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.
Govinda Ojha contact
Kishore R Pradhan, MD principal investigator
Tilganga Institute of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Small incision lenticule extraction and ReLEx® (SMILE) in people with Hyperopia, run by Tilganga Institute of Ophthalmology at 1 site in Nepal.
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 15 inclusion and 7 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 25 Apr 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 Nepal. 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 Kishore R Pradhan, MD (009779803397021, drkishoreraj@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of corrected distance visual acuity (change in corrected distance visual acuity) (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?
On the ClinicalTrials.gov record for NCT02316041, 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 25 Apr 2018.