Clinical investigation of the femtosecond laser system for the refractive correction of hyperopic eyes by means of lenticule extraction.

Not Applicable

• Registration Number: CTRI/2010/091/000685
• Lead Sponsor: Mr. Samir ShahNew Vision Laser Centers (Rajkot) Pvt. Ltd. 203, Embassy Building, Jawahar Road, Opp. Jubilee Baug, Rajkot 360 001.Gujarat, India. Ph: (0281) 2240241, 2240239 Fax: (0281) 2240239

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Older than 21
Central corneal thickness > 500 urn and calculated residual stroma thickness > 250 urn
Normal cornea topography
No prior refractive surgery
The patients commit themselves to taking part in the post-surgery examinations planned for
the clinical investigation.
Patients who wear contact lenses should stop wearing their lenses 4 weeks before the
preliminary examination in the case of hard lenses and 2 weeks before in the case of soft
lenses.
Patients should exhibit one of the following vision defects:

a)Subjective hyperopia (SPH) of up to +8 D of natural cause, measured at the cornea level
b)Subjective astigmatism (CYL) of up to 5 D, natural cause
c)Spherocylindrical combinations of up to +8 D SEQ

There are no restrictions regarding gender or race.
The patients must sign a patient consent declaration which explains the conditions under
which they take part in the clinical investigation, the alternative treatment types and the risks.

Exclusion Criteria

Patients who cannot lie flat and still for a short period
Patients who are not capable of making themselves understood or giving their consent
Known allergies or intolerances to medications administered
Immunosuppressed patients, e.g. patients with AIDS or autoimmune disorders
Treatment with medication which influence wound healing, e.g. steroids, antimetabolites and
immunosuppressors
Diagnosis of diabetes or connective tissue disorders
Pregnant and breastfeeding women, plus women who are planning a pregnancy in the period
of the clinical study
Unstable refraction
Any residual, recurrent, or acute ocular disease or abnormality of the eye to be treated.
Cataract Suspected glaucoma or intraocular pressure >21mm Hg
Disease of the cornea Disease involving thinning of the cornea such as keratoconus and
pellucid marginal degeneration
Dystrophy of basement membrane
Exudative macular degeneration
Infections and inflammations of the eye, e.g. uveitis, iritis, blepharitis
Existing, recurrent, or acute ocular disease or abnormality of the eye to be treated.
Existing corneal implant
Lesion or scarring of the cornea
Herpes simplex or herpes zoster keratitis
Dry eyes
Participation in other ophthalmic studies

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.The change in refraction in the periods between 12 and 24 weeks and between 24 and 36 weeks after the surgery determined to assess the stability of the treatment.<br><br>2.The deviation from the target refraction per eye is used to determine the reproducibility of the procedure. At least 50% of the eyes should meet the target refraction within &plusmn; 0.5 D and 75% within 1 D.<br>A variability of &plusmn; 0.25 D is within the limits of biological variability and the measurement accuracy of the procedure.<br><br>Timepoint: 12 and 24 weeks and between 24 and 36 weeks.;Best Spectacle-Corrected Visual Acuity (BSCVA) or Uncorrected Visual Acuity (UCVA) is determined at the defined times by means of a standard vision test.Timepoint: after 24 and 36 weeks

Secondary Outcome Measures

Name	Time	Method
ILTimepoint: NI