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

• Conditions: Refractive correction of Hyperopic eyes.

• 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

The prospective single arm non randomize clinical study to demonstrate the safety and feasibility of using the femtosecond laser system for the refractive correction of hyperopic eyes. The study will be conducted at single center in India and planned as a single group, no control group study.The primary objective is to document Improvement of uncorrected visual acuity for far sight vision (UCVA) andchange in refraction in the periods between 12 and 24 weeks and between 24 and 36 weeks after the operation is determined to assess the stability of the treatmentThe secondary outcomes will be to determine the astigmatism of the participants before and at specified times after the operation.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Older than 21Central corneal thickness > 500 urn and calculated residual stroma thickness > 250 urnNormal cornea topographyNo prior refractive surgeryThe patients commit themselves to taking part in the post-surgery examinations planned forthe clinical investigation.Patients who wear contact lenses should stop wearing their lenses 4 weeks before thepreliminary examination in the case of hard lenses and 2 weeks before in the case of softlenses.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 levelb)Subjective astigmatism (CYL) of up to 5 D, natural causec)Spherocylindrical combinations of up to +8 D SEQThere are no restrictions regarding gender or race.The patients must sign a patient consent declaration which explains the conditions underwhich 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 periodPatients who are not capable of making themselves understood or giving their consentKnown allergies or intolerances to medications administeredImmunosuppressed patients, e.g. patients with AIDS or autoimmune disordersTreatment with medication which influence wound healing, e.g. steroids, antimetabolites andimmunosuppressorsDiagnosis of diabetes or connective tissue disordersPregnant and breastfeeding women, plus women who are planning a pregnancy in the periodof the clinical studyUnstable refractionAny residual, recurrent, or acute ocular disease or abnormality of the eye to be treated.Cataract Suspected glaucoma or intraocular pressure >21mm HgDisease of the cornea Disease involving thinning of the cornea such as keratoconus andpellucid marginal degenerationDystrophy of basement membraneExudative macular degenerationInfections and inflammations of the eye, e.g. uveitis, iritis, blepharitisExisting, recurrent, or acute ocular disease or abnormality of the eye to be treated.Existing corneal implantLesion or scarring of the corneaHerpes simplex or herpes zoster keratitisDry eyesParticipation in other ophthalmic studies.

Study & Design

• Study Type: Not specified
• 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.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 ± 0.5 D and 75% within 1 D.A variability of ± 0.25 D is within the limits of biological variability and the measurement accuracy of the procedure.	12 and 24 weeks and between 24 and 36 weeks.

Trial Locations

Locations (1)

New Vision Laser Center; 🇮🇳 Vadodara, GUJARAT, India

New Vision Laser Center

🇮🇳Vadodara, GUJARAT, India

Dr. Rupal Shah

Principal investigator

rupal@newvisionindia.com