se of the VisuMax femtosecond laser lenticule removal procedure for the correction of hyperopia with or without astigmatism

Phase 2

• Conditions: H52.0; Hypermetropia

• Registration Number: DRKS00013324
• Lead Sponsor: Carl Zeiss Meditec AG

Brief Summary

Results: The preoperative spherical equivalent was +3.20 ± 1.48 D (range: +0.25 to +6.50 D). At the 12-month follow-up visit, 81% of eyes treated were within ±0.50 D and 93% of eyes were within ±1.00 D of intended correction. A total of 1.2% of eyes lost two or more lines of CDVA at the 12-month follow-up visit, and 83% were at least 20/20, corresponding to a safety index of 1.005 at 12 months. Of the 219 eyes with plano target, 68.8% had an uncorrected distance visual acuity of 20/20 or better and 88% were at least 20/25 uncorrected at 12 months. There were no statistically significant changes in contrast sensitivity. Conclusions: SMILE was found to be an effective treatment method for the correction of compound hyperopic astigmatism, demonstrating a high level of efficacy, predictability, safety, and stability. [J Refract Surg. 2022;38(12):760-769.].

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-28
• Study Completion: 2020-10-15
• Results First Posted: 2022-12-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

Normal corneal topography;
- Predicted post-operative keratometry =51 D;
- Contact lens wearers must stop wearing their contact lenses before baseline measurements according to local requirements of the clinic;
- Patients should be able to understand the patient information and willing to sign an informed consent;
- Patients should be willing to comply with all follow-up visits and the respective examinations;
- Patients with hyperopia or hyperopia with astigmatism (attempted correction: sphere up to +6.00D, cylinder up to 5.00D and maximum hyperopic meridian up to +7.00D);
- The corrected distance visual acuity should be 20/25 or better in each eye pre-operatively;
- A difference between cycloplegic and manifest refractions of =1.00 D spherical equivalent in the eye to be treated;

Exclusion Criteria

- The patients presenting at least one of the characteristics as described for exclusion criteria in the documentation set of the VisuMax laser keratome ReLEx SMILE option.
- Mixed astigmatism
- Any impaired person (minors, pregnant or breast feeding women or persons incapable of giving consent) are definitely excluded from the study.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To provide evidence of the safety and effectiveness of the lenticule extraction method SMILE for hyperopia, the following parameter are measured postoperatively at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months and 12 months:<br>uncorrected visual acuity (UDVA)<br>subjective refraction (sphere, cylinder, axis)<br>best corrected visual acuity (CDVA)<br>

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints include analysis of a patient questionnaire on visual quality and contrast sensitivity evaluated at 3, 6, 9 and 12 months postoperatively compared to preoperatively. Furthermore, the shape of the corneal surface, the side effects and further detailed analyzes of visual acuity and refraction are presented at 1 week, as well as at 1, 3, 6, 9 and 12 months postoperatively.