Evaluating lenticule sizes for correcting myopic astigmatism with SMILE
Evaluation of Different Lenticule Diameters in Myopic Astigmatism Correction With SMILE Procedures
This study is testing whether using different sizes of lenses during the SMILE procedure can improve vision and safety for people with myopic astigmatism.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Al Watany Eye Hospital Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06062004 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of different lenticule diameters on the safety and effectiveness of the SMILE procedure for correcting myopic astigmatism. Participants will undergo the SMILE procedure on both eyes, with one eye receiving a standard 6.5 mm lenticule diameter and the other a larger 7.0 mm diameter. The study aims to assess visual outcomes, including immediate visual acuity and contrast sensitivity, while also monitoring for any intra-operative or post-operative complications. A total of 50 participants aged 18 to 50 with specific criteria will be enrolled in this comparative, prospective study.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 50 with myopic astigmatism ranging from -1.0 D to -10.00 D spherical equivalent.
Not a fit: Patients with thin corneas, previous ocular surgeries, or certain ocular pathologies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the effectiveness of SMILE procedures for patients with myopic astigmatism, leading to better visual outcomes.
How similar studies have performed: While there have been studies on SMILE procedures, this specific approach of varying lenticule diameters is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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
Where this trial is running
Cairo
- Al Watany Eye Hospital — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Sherine Shafik, PhD
- Email: s_shafik@hotmail.com
- Phone: 00201222421896
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.