Comparison of two refractive surgery techniques ReLEx SMILE and PRK for the correction of low degrees of short sightedness
- Conditions
- Patients with low degrees of myopia (Spherical equivalent of -4D)
- Registration Number
- CTRI/2014/10/005084
- Lead Sponsor
- NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL
- Brief Summary
A prospective study comparing the two refractive procedures ReLEx SMILE and PRK in patients between the age of 21 years and 40 years in terms of visual and refractive outcomes and patient satisfaction for the correction of low myopia (Spherical equivalent < -4D) will be conducted over a period of 6 months.
**PREOPERATIVE PARAMETERS**
**Patient demographic parameters**:
· Patient(N)
· Sex(M/F)
· Age(Y)
**Visual parameters**:
· UCVA
· BSCVA
· Manifest refraction: Magnitude of Sphere (D), Magnitude of Cylinder(D), Spherical equivalent(D).
· Retinoscopy refraction
**Pre-op Assessment**
· Anterior segment (Slit lamp biomicroscopy)
· Dilated Fundus of the eye including periphery (Indirect ophthalmoscopy)
· Intraocular Pressure (NCT)
· Axial length (IOL Master)
· Topography (Orbscan II and Sirius)
· Aberrometry and pupil size (I trace)
· Contrast Sensitivity (FACT)
· Specular Microscopy (ECD)
· Dry eye assessment (Shirmers I, II and TBUT)
**POST-OPERATIVEPARAMETERS**
**FOLLOW UP EXAMINATION SCHEDULE - Day 1, 15and 3 months post op**
**Follow-up examination -1 day postop for ReLEx SMILE & day 4 postop PRK**
· Uncorrected distant Visual acuity (in Logmar, ETDRScharts at 6m)
· SL Exam – Corneal state, haze
· AE
**Follow-up examination(15 days postop)**
· Uncorrected distant Visual acuity (in Logmar, ETDRScharts at 4m)
· Subjective refraction
· IOP (NCT)
· Topography (Orbscan + Sirius + CRS Master)
· Aberrations (I Trace)
· AS-OCT – epithelial thickness profile
· Contrast sensitivity( FACT)
· AE
· Subjective questionnaire
**Follow-up examination(3 months postop)**
· Uncorrected distant Visual acuity (in Logmar, ETDRScharts at 4m)
· Subjective refraction
· IOP (NCT)
· Topography (Orbscan+Sirius + CRS Master)
· Aberrations (I Trace)
· AS-OCT – epithelial thickness profile
· Contrast sensitivity( FACT)
· AE
· Subjective assessment(questionnaire) satisfaction, spectacle independence, Halo and glare assessment
· Dry eye assessment (Shirmers I, II, TBUT)
· Specular Microscopy (ECD)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 60
- •Myopia with SEQ <.
- 4 D with cylinder upto.
- 2 D •Stable corneal conditions within the last 12 months •Stable refraction since past 12 months (<0.5D change within past 12 months) •Healthy ocular surface with stable tear film •Discontinuation of Soft contact lenses 1 week, and rigid contact lenses 3 weeks prior to surgery.
•Thin corneas (Corneal pachymetry <480u) •Steep corneas Kmax >48 D •Keratoconus suspects or frank keratoconus •Mixed astigmatism •Moderate to severe dry eye (Shirmers1 <10 mm) •Socket / globe /lid anomalies – very deep set eyes, nanophthalmos •Severe meibomian gland disease, lid abnormalities •Severe atopy •Contact lens overuse •Pregnant and nursing mother •Autoimmune disorders •Pts on systemic medications eg Iso retinoic acid, hormonal preperations, OCPs, antidepressants.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Matched population comparison of refractive and visual outcomes and patient satisfaction between ReLEx SMILE and PRK for the correction of low myopia (SEQ 4D) 6 months
- Secondary Outcome Measures
Name Time Method Not Applicable Not Applicable
Trial Locations
- Locations (1)
NETHRADHAMA SUPER SPECIALITY EYE HOSPITAL, PHACO AND REFRACTIVE DEPARTMENT,
🇮🇳Bangalore, KARNATAKA, India
NETHRADHAMA SUPER SPECIALITY EYE HOSPITAL, PHACO AND REFRACTIVE DEPARTMENT,🇮🇳Bangalore, KARNATAKA, IndiaDR UTSAV PATELPrincipal investigator09901903149utsav_5093@yahoo.com