Refractive ErrorsNCT06062004
Evaluation of Different Lenticule Diameters in Myopic Astigmatism Correction With SMILE Procedures
A study testing Small Incision Lenticule Extraction (SMILE) in people with Refractive Errors and Myopic Astigmatism, run by Al Watany Eye Hospital at 1 site in Egypt.
Trial summary
Small incision lenticule extraction (SMILE) is a refractive intrastromal procedure for myopia and myopic astigmatism correction. Most of the studies evaluating astigmatic correction by SMILE reported astigmatic under-correction, especially in high degrees of astigmatism. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Refractive Errors, Myopic Astigmatism
- What is being tested?
- Small Incision Lenticule Extraction (SMILE)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Nov 2018to 30 Apr 2024
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age groups between 18 and 50 years
- Myopic astigmatism with up to -10.00 D spherical equivalent (SE) and a minimum astigmatism of -1.0 D and a maximum of -5 D. The astigmatism will be divided into low astigmatism (<0.75 D), moderate astigmatism (1.5- 3 D) and high astigmatism (>3 D).
- Corrected distance visual acuity (CDVA) of 0.7 or better (decimal)
Who cannot join
- Thin corneas (< 490 μm)
- Proven or suspicious cases of corneal ectatic conditions by corneal tomography
- Previous ocular surgeries
- Patients taking systemic steroids, immunosuppressants, oral contraceptives, or antidepressants
- Pregnant females
- Corneal scars or any ocular pathology likely to affect visual outcomes
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Al Watany Eye Hospital
Cairo, 11775
Mohamed El Bahrawy, PhD, 00201144777100, bahrawy.mohamed@gmail.com
About this study
Small incision lenticule extraction (SMILE) is a refractive intrastromal procedure for myopia and myopic astigmatism correction. Most of the studies evaluating astigmatic correction by SMILE reported astigmatic under-correction, especially in high degrees of astigmatism.
This under-correction could be due to: first, the active eye tracker or the iris registration is not yet available to overcome the cyclotorsion that occurred during the treatment with the VisuMax femtosecond laser system (Carl Zeiss Meditec, Jena, Germany) which could be overcome by manual compensation technique, especially in higher degrees of cylinders (> 1.5 diopters (D)). Second, in patients with small lenticule diameters, the more abrupt change in thickness at the edge of the treated area could induce more stromal and epithelial healing in this area. Thus, the astigmatic correction would be less effective with small than large lenticule diameters for similar high preoperative astigmatism.
This study assessed the outcome of using a 0.5 millimeter (mm) larger lenticule diameter in the fellow eyes of myopic astigmatic correction SMILE participants. This assessment included the safety and effectiveness indices, the refractive and visual outcomes, the contrast sensitivity, and some morphological outcomes such as corneal curvature and epithelial and corneal thickness.
Read the detailed description
Study Title: Evaluation of different lenticule diameters in myopic astigmatic correction with SMILE procedures Primary Investigator: Dr. Ahmed Sedky (Eye Subspecialty Center, Cairo, Egypt, 18 Elkhalifa Elmamoun Street, Heliopolis, Cairo, Egypt) Co-Investigators: Sherine S Wahba, Maged M Roshdy, Nermeen A Refaat Study Objectives Primary Objective: To study the effect of changing the lenticule diameter on the safety and effectiveness of myopic astigmatism correction with the SMILE procedure.
Secondary Objective: To compare other outcomes such as visual outcomes including immediate visual acuity, contrast sensitivity, and epithelial remodeling.
Participants and Methods:
Study Setting: Eye Subspecialty Center, Cairo, Egypt, 18 Elkhalifa Elmamoun Street, Heliopolis, Cairo, Egypt and Al Watany Eye Hospital, Althawra Street, Cairo, Egypt Study design: Hospital-based, comparative, prospective, interventional contralateral eye study Sample size and randomization: 50 participants fulfilling the inclusion criteria will be enrolled in the study. Their right eyes undergo SMILE procedure using the standard 6.5 mm lenticule diameter and their left eyes undergo SMILE procedure but using a larger lenticule diameter of 7.0 mm.
Ethical issues:
Institutional ethics committee approval will be obtained. Participants' informed consent will be taken and the procedure explained to them in their own language. Any intra-operative or post-operative complications occurring in either group will be documented and duly informed to the ethics committee
Preoperative evaluation:
- Anterior and posterior segment clinical examination
- Uncorrected distance visual acuity (UDVA) in decimal and logMAR units
- Corrected distance visual acuity (CDVA) in decimal and logMAR units
- Corneal tomography using the Pentacam high resolution (HR) (Oculus Optikgeräte, Wetzlar, Germany) including the flattest and steepest meridians (in keratometric diopters (D), the axes (in degrees)
- Contrast sensitivity (CSV1000E test (Good-Lite, Elgin, Illinois, USA)) in 4 different special frequencies
- Anterior segment Optical Coherence Tomography (Cirrus, Carl Zeiss Meditec, Jena, Germany) measurement of total corneal and epithelial thickness in µm Study duration: 3 months for recruitment of the patients.
Surgical technique:
All surgeries will be performed under topical anesthesia using the VisuMax femtosecond laser with the following parameters:
Cap thickness of 120 μm Cap diameter is either 7.5 mm for lenticule diameter 6.5 mm or 8.0 mm for lenticule diameter 7.0 mm.
Cap side cut angle 70° 3 mm incision positioned at 100° and angled at 45° A transition zone of 0.1 mm and clearance of 0.5 mm Lenticule side cut angle of 90° and edge lenticule thickness of 15 μm Directly preoperative, the limbus will be marked in the 0° to 180° axis with a marker pen in the upright head position on the slit lamp. Then, the patient will be positioned under the VisuMax femtosecond laser and instructed to look into the green flashing fixation light. Once proper centration is achieved, the eye will be docked to the patient interface and suction will be applied.
Manual compensation will be done by gently rotating the contact glass to align the horizontal marks on the eye to the 0° to 180° axis. Once both are aligned, the laser process will be done to create the refractive lenticule followed by its dissection and washing of the interface by a balanced salt solution.
Medication: will be the standard treatment; topical steroids and antibiotics 4 times per day for 10 days and tear substitutes 4 times daily for one to two months.
Postoperative evaluation:
Follow-up of the subjects will be done in 1 day, 1 week, 3 months, and 6 months.
Data will be collected for analysis starting from 1 week, including:
- Uncorrected distance visual acuity (UDVA) in decimal and logMAR units
- Corrected distance visual acuity (CDVA) in decimal and logMAR units
- Corneal tomography using the Pentacam HR (Oculus Optikgeräte GmbH, Wetzlar, Germany) including the flattest and steepest meridians (in diopters (D), the axes (in degree)
- Contrast sensitivity (CSV1000E test (Good-Lite, Elgin, IL, USA)) in 4 different special frequencies
- Anterior segment Optical Coherence Tomography (Cirrus HD-OCT, Carl Zeiss Meditec, Jena, Germany) measurement of total corneal and epithelial thickness in µm.
- Conditions
- Refractive Errors, Myopic Astigmatism
- Being tested
- Small Incision Lenticule Extraction (SMILE)
- Keywords
- SMILE, Myopia, Refractive Surgery, Astigmatism, Small Incision Lenticule Extraction
- Medical subject headings
- Refractive Errors, Astigmatism, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small Incision Lenticule Extraction (SMILE)Procedure or surgery
All surgeries will be performed under topical anesthesia using the VisuMax femtosecond laser with the following parameters:
- Cap thickness of 120 μm
- Cap diameter of 1 mm larger than the lenticule diameter
- Cap side cut angle 70°
- 3 mm incision positioned at 100° and angled at 45°
- Transition zone of 0.1 mm and clearance of 0.5 mm
- Lenticule side cut angle of 90° and edge lenticule thickness of 15 μm
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | group A, SMILE procedure with lenticule diameter of 6.5 mm Receives: Procedure: Small Incision Lenticule Extraction (SMILE) |
| Study cases | Active comparator | group B, SMILE procedure with lenticule diameter of 7.0 mm Receives: Procedure: Small Incision Lenticule Extraction (SMILE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety index of using 7 and 6.5 mm lenticule diameters SMILE to treat myopic astigmatism
The safety index (unitless parameter) is calculated as postoperative CDVA/ preoperative CDVA (both in decimal units).
Measured: up to 6 months
The efficacy index of using 7 and 6.5 mm lenticule diameters SMILE to treat myopic astigmatism
The efficacy index (unitless parameter) is calculated as postoperative UDVA/ preoperative CDVA (both in decimal units).
Measured: up to 6 months
Secondary outcomes (5)
Refractive outcomes of using 7 and 6.5 mm lenticule diameters SMILE to treat myopic astigmatism.
To compare subjective refractive outcomes including spherical equivalent and residual astigmatism (in diopters) of SMILE procedure using 7 and 6.5 mm lenticule diameters SMILE to treat myopic astigmatism.
Measured: up to 6 months
Visual acuity outcomes of using 7 and 6.5 mm lenticule diameters SMILE to treat myopic astigmatism.
To compare postoperative UDVA and CDVA (in logMAR) of SMILE procedure using 7 and 6.5 mm lenticule diameters SMILE to treat myopic astigmatism.
Measured: up to 6 months
Contrast sensitivity outcomes of using 7 and 6.5 mm lenticule diameters SMILE to treat myopic astigmatism.
To compare postoperative photopic and mesopic contrast sensitivity (in log unit) at 3, 6, 12, and 18 cycles per degree of SMILE procedure using 7 and 6.5 mm lenticule diameters SMILE to treat myopic astigmatism. This will be done using the CSV1000E device (Good-Lite, Elgin, IL, USA)
Measured: up to 6 months
Corneal curvature changes after SMILE procedure using 7 and 6.5 mm lenticule diameters SMILE to treat myopic astigmatism.
To compare postoperative corneal curvature in flattest and steepest meridia (in keratometric diopters) after SMILE procedure using 7 and 6.5 mm lenticule diameters SMILE to treat myopic astigmatism. This will be done using the Pentacam high resolution (HR) (Oculus Optikgeräte, Wetzlar, Germany).
Measured: up to 6 months
Corneal structural changes after SMILE procedure using 7 and 6.5 mm lenticule diameters SMILE to treat myopic astigmatism.
To compare postoperative and central corneal and epithelial thickness (in micrometers) and standard deviation of epithelial thickness in different locations (in micrometers) after SMILE procedure using 7 and 6.5 mm lenticule diameters SMILE to treat myopic astigmatism. This will be done using the anterior segment OCT (Cirrus HD-OCT, Carl Zeiss Meditec, Jena, Germany)
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start27 Nov 2018
- Primary completion28 Feb 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Refractive ErrorsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Hospital-based, comparative, prospective, interventional contralateral eye study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al Watany Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062004
- Sponsor's protocol ID
- REF-2018-003
- Status last verified
- Sep 2023
- First submitted
- 12 Jul 2023
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sekundo W, Kunert KS, Blum M. Small incision corneal refractive surgery using the small incision lenticule extraction (SMILE) procedure for the correction of myopia and myopic astigmatism: results of a 6 month prospective study. Br J Ophthalmol. 2011 Mar;95(3):335-9. doi: 10.1136/bjo.2009.174284. Epub 2010 Jul 3.
PubMed 20601657Zhang J, Wang Y, Wu W, Xu L, Li X, Dou R. Vector analysis of low to moderate astigmatism with small incision lenticule extraction (SMILE): results of a 1-year follow-up. BMC Ophthalmol. 2015 Jan 24;15:8. doi: 10.1186/1471-2415-15-8.
PubMed 25618419Ivarsen A, Hjortdal J. Correction of myopic astigmatism with small incision lenticule extraction. J Refract Surg. 2014 Apr;30(4):240-7. doi: 10.3928/1081597X-20140320-02.
PubMed 24702575Ganesh S, Brar S, Pawar A. Results of Intraoperative Manual Cyclotorsion Compensation for Myopic Astigmatism in Patients Undergoing Small Incision Lenticule Extraction (SMILE). J Refract Surg. 2017 Aug 1;33(8):506-512. doi: 10.3928/1081597X-20170328-01.
PubMed 28787514Pedersen IB, Ivarsen A, Hjortdal J. Changes in Astigmatism, Densitometry, and Aberrations After SMILE for Low to High Myopic Astigmatism: A 12-Month Prospective Study. J Refract Surg. 2017 Jan 1;33(1):11-17. doi: 10.3928/1081597X-20161006-04.
PubMed 28068441
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Lenticule Diameters in Myopic Astigmatism Correction With SMILE Procedures
- ClinicalTrials.gov ID
- NCT06062004
- Acronym / sponsor ID
- REF-2018-003
- Conditions
- Refractive Errors, Myopic Astigmatism
- Keywords
- SMILE, Myopia, Refractive Surgery, Astigmatism, Small Incision Lenticule Extraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Al Watany Eye HospitalUniversity, hospital or other
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 2 Oct 2023 (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.
Small incision lenticule extraction (SMILE) is a refractive intrastromal procedure for myopia and myopic astigmatism correction. Most of the studies evaluating astigmatic correction by SMILE reported astigmatic under-correction, especially in high degrees of astigmatism.
This under-correction could be due to: first, the active eye tracker or the iris registration is not yet available to overcome the cyclotorsion that occurred during the treatment with the VisuMax femtosecond laser system (Carl Zeiss Meditec, Jena, Germany) which could be overcome by manual compensation technique, especially in higher degrees of cylinders (> 1.5 diopters (D)). Second, in patients with small lenticule diameters, the more abrupt change in thickness at the edge of the treated area could induce more stromal and epithelial healing in this area. Thus, the astigmatic correction would be less effective with small than large lenticule diameters for similar high preoperative astigmatism.
This study assessed the outcome of using a 0.5 millimeter (mm) larger lenticule diameter in the fellow eyes of myopic astigmatic correction SMILE participants. This assessment included the safety and effectiveness indices, the refractive and visual outcomes, the contrast sensitivity, and some morphological outcomes such as corneal curvature and epithelial and corneal thickness.
Detailed description
Study Title: Evaluation of different lenticule diameters in myopic astigmatic correction with SMILE procedures Primary Investigator: Dr. Ahmed Sedky (Eye Subspecialty Center, Cairo, Egypt, 18 Elkhalifa Elmamoun Street, Heliopolis, Cairo, Egypt) Co-Investigators: Sherine S Wahba, Maged M Roshdy, Nermeen A Refaat Study Objectives Primary Objective: To study the effect of changing the lenticule diameter on the safety and effectiveness of myopic astigmatism correction with the SMILE procedure.
Secondary Objective: To compare other outcomes such as visual outcomes including immediate visual acuity, contrast sensitivity, and epithelial remodeling.
Participants and Methods:
Study Setting: Eye Subspecialty Center, Cairo, Egypt, 18 Elkhalifa Elmamoun Street, Heliopolis, Cairo, Egypt and Al Watany Eye Hospital, Althawra Street, Cairo, Egypt Study design: Hospital-based, comparative, prospective, interventional contralateral eye study Sample size and randomization: 50 participants fulfilling the inclusion criteria will be enrolled in the study. Their right eyes undergo SMILE procedure using the standard 6.5 mm lenticule diameter and their left eyes undergo SMILE procedure but using a larger lenticule diameter of 7.0 mm.
Ethical issues:
Institutional ethics committee approval will be obtained. Participants' informed consent will be taken and the procedure explained to them in their own language. Any intra-operative or post-operative complications occurring in either group will be documented and duly informed to the ethics committee
Preoperative evaluation:
- Anterior and posterior segment clinical examination
- Uncorrected distance visual acuity (UDVA) in decimal and logMAR units
- Corrected distance visual acuity (CDVA) in decimal and logMAR units
- Corneal tomography using the Pentacam high resolution (HR) (Oculus Optikgeräte, Wetzlar, Germany) including the flattest and steepest meridians (in keratometric diopters (D), the axes (in degrees)
- Contrast sensitivity (CSV1000E test (Good-Lite, Elgin, Illinois, USA)) in 4 different special frequencies
- Anterior segment Optical Coherence Tomography (Cirrus, Carl Zeiss Meditec, Jena, Germany) measurement of total corneal and epithelial thickness in µm Study duration: 3 months for recruitment of the patients.
Surgical technique:
All surgeries will be performed under topical anesthesia using the VisuMax femtosecond laser with the following parameters:
Cap thickness of 120 μm Cap diameter is either 7.5 mm for lenticule diameter 6.5 mm or 8.0 mm for lenticule diameter 7.0 mm.
Cap side cut angle 70° 3 mm incision positioned at 100° and angled at 45° A transition zone of 0.1 mm and clearance of 0.5 mm Lenticule side cut angle of 90° and edge lenticule thickness of 15 μm Directly preoperative, the limbus will be marked in the 0° to 180° axis with a marker pen in the upright head position on the slit lamp. Then, the patient will be positioned under the VisuMax femtosecond laser and instructed to look into the green flashing fixation light. Once proper centration is achieved, the eye will be docked to the patient interface and suction will be applied.
Manual compensation will be done by gently rotating the contact glass to align the horizontal marks on the eye to the 0° to 180° axis. Once both are aligned, the laser process will be done to create the refractive lenticule followed by its dissection and washing of the interface by a balanced salt solution.
Medication: will be the standard treatment; topical steroids and antibiotics 4 times per day for 10 days and tear substitutes 4 times daily for one to two months.
Postoperative evaluation:
Follow-up of the subjects will be done in 1 day, 1 week, 3 months, and 6 months.
Data will be collected for analysis starting from 1 week, including:
- Uncorrected distance visual acuity (UDVA) in decimal and logMAR units
- Corrected distance visual acuity (CDVA) in decimal and logMAR units
- Corneal tomography using the Pentacam HR (Oculus Optikgeräte GmbH, Wetzlar, Germany) including the flattest and steepest meridians (in diopters (D), the axes (in degree)
- Contrast sensitivity (CSV1000E test (Good-Lite, Elgin, IL, USA)) in 4 different special frequencies
- Anterior segment Optical Coherence Tomography (Cirrus HD-OCT, Carl Zeiss Meditec, Jena, Germany) measurement of total corneal and epithelial thickness in µm.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Hospital-based, comparative, prospective, interventional contralateral eye study
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Small Incision Lenticule Extraction (SMILE)group A, SMILE procedure with lenticule diameter of 6.5 mm |
| Study cases | Active comparator | Procedure: Small Incision Lenticule Extraction (SMILE)group B, SMILE procedure with lenticule diameter of 7.0 mm |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age groups between 18 and 50 years
- Myopic astigmatism with up to -10.00 D spherical equivalent (SE) and a minimum astigmatism of -1.0 D and a maximum of -5 D. The astigmatism will be divided into low astigmatism (<0.75 D), moderate astigmatism (1.5- 3 D) and high astigmatism (>3 D).
- Corrected distance visual acuity (CDVA) of 0.7 or better (decimal)
Key exclusion criteria (6 listed)
- Thin corneas (< 490 μm)
- Proven or suspicious cases of corneal ectatic conditions by corneal tomography
- Previous ocular surgeries
- Patients taking systemic steroids, immunosuppressants, oral contraceptives, or antidepressants
- Pregnant females
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 Extraction (SMILE)All surgeries will be performed under topical anesthesia using the VisuMax femtosecond laser with the following parameters: * Cap thickness of 120 μm * Cap diameter of 1 mm larger than the lenticule diameter * Cap side cut angle 70° * 3 mm incision positioned at 100° and angled at 45° * Transition zone of 0.1 mm and clearance of 0.5 mm * Lenticule side cut angle of 90° and edge lenticule thickness of 15 μm | Procedure or surgery | Control, Study cases |
Primary outcome
The safety index of using 7 and 6.5 mm lenticule diameters SMILE to treat myopic astigmatism
Time frame: up to 6 months
The safety index (unitless parameter) is calculated as postoperative CDVA/ preoperative CDVA (both in decimal units).
The efficacy index of using 7 and 6.5 mm lenticule diameters SMILE to treat myopic astigmatism
Time frame: up to 6 months
The efficacy index (unitless parameter) is calculated as postoperative UDVA/ preoperative CDVA (both in decimal units).
5 secondary outcomes
Refractive outcomes of using 7 and 6.5 mm lenticule diameters SMILE to treat myopic astigmatism.
Time frame: up to 6 months
Visual acuity outcomes of using 7 and 6.5 mm lenticule diameters SMILE to treat myopic astigmatism.
Time frame: up to 6 months
Contrast sensitivity outcomes of using 7 and 6.5 mm lenticule diameters SMILE to treat myopic astigmatism.
Time frame: up to 6 months
Corneal curvature changes after SMILE procedure using 7 and 6.5 mm lenticule diameters SMILE to treat myopic astigmatism.
Time frame: up to 6 months
Corneal structural changes after SMILE procedure using 7 and 6.5 mm lenticule diameters SMILE to treat myopic astigmatism.
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Background: PubMed 20601657Sekundo W, Kunert KS, Blum M. Small incision corneal refractive surgery using the small incision lenticule extraction (SMILE) procedure for the correction of myopia and myopic astigmatism: results of a 6 month prospective study. Br J Ophthalmol. 2011 Mar;95(3):335-9. doi: 10.1136/bjo.2009.174284. Epub 2010 Jul 3.
- Background: PubMed 25618419Zhang J, Wang Y, Wu W, Xu L, Li X, Dou R. Vector analysis of low to moderate astigmatism with small incision lenticule extraction (SMILE): results of a 1-year follow-up. BMC Ophthalmol. 2015 Jan 24;15:8. doi: 10.1186/1471-2415-15-8.
- Background: PubMed 24702575Ivarsen A, Hjortdal J. Correction of myopic astigmatism with small incision lenticule extraction. J Refract Surg. 2014 Apr;30(4):240-7. doi: 10.3928/1081597X-20140320-02.
- Background: PubMed 28787514Ganesh S, Brar S, Pawar A. Results of Intraoperative Manual Cyclotorsion Compensation for Myopic Astigmatism in Patients Undergoing Small Incision Lenticule Extraction (SMILE). J Refract Surg. 2017 Aug 1;33(8):506-512. doi: 10.3928/1081597X-20170328-01.
- Background: PubMed 28068441Pedersen IB, Ivarsen A, Hjortdal J. Changes in Astigmatism, Densitometry, and Aberrations After SMILE for Low to High Myopic Astigmatism: A 12-Month Prospective Study. J Refract Surg. 2017 Jan 1;33(1):11-17. doi: 10.3928/1081597X-20161006-04.
- 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 Small Incision Lenticule Extraction (SMILE) in people with Refractive Errors and Myopic Astigmatism, run by Al Watany Eye Hospital 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 3 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 2 Oct 2023. 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 Sherine Shafik, PhD (00201222421896, s_shafik@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety index of using 7 and 6.5 mm lenticule diameters SMILE to treat myopic astigmatism (time frame: up to 6 months). The study lists 2 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 NCT06062004, which also lists 5 linked publications.
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 2 Oct 2023.