A clinical study to compare the pressure in eye before and after refractive surgery in Indian myopic eyes.

Not yet recruiting

• Conditions: Myopia,

• Registration Number: CTRI/2019/11/021938
• Lead Sponsor: Dr Shiva Kushwah

Brief Summary

This is an observational study to assess the pre & post intraocular pressure(IOP) status following Small Inscision Lenticule Extraction Femtolasik &  Lasik in the presence of altered corneal thickness & biomechanics in Indian myopic eyes and also to establish a nomogram to correlate between the apparent & real  IOP using CORVIS ST NON CONTACT TONOMETER & APPLANATION TONOMETER & to to use the most suitable method to evaluate IOP in post refractive eyes . All myopic patients fulfilling  the inclusion crietaria will be registered for the study & IOP will be measured before the surgery then after surgery at 1 weeks 4 weeks 8 weeks & 12 weeks.Statistical analysis will be performed by using descriptiveand inferential statistics using chi square test/fisher exact test forcategorical data. Independent sample t-test to comparemean values between the two groups and ANOVA followed by post-hoc test will beused to compare mean values between more than two groups.Paired t-test will be used to see therelative change with respect to time. Any other test if applicable at the time of analysis will be used. P-value less than 0.05 considered as significant at95% confidence level. The statistical software SPSS version24.0 or higher will be used in the analysis. Primary outcome  can be seen at 3 months of each participant enrolled and nomogram will be prepared at one year of study.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-05-11
• Study Start: 2019-09-11

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

age group between 20 to 30 years Both sex Clear cornea Astigmatism less than 1D Myopia of 2D to 5D Refraction stable for past 1 years(+/- 0.5Diopter) Indian ethnicity Central corneal thickness 520 to 550µm.

Exclusion Criteria

• Age less than 20 years or more than 30 years Any history of systemic illness like Diabetes, Hypertension, Asthma, collagen vascular disease, pregnancy ocular injuries.
• Family history of glaucoma Hypermetropia Astigmatism more than 1D Myopic less than 2D or more than 5D Corneal pathology such as scarring & keratoconus Patients with history of any previous ocular surgery.
• Ethnicity other than Indian.
• Central corneal thickness less than 520 µm or more than 550µm Steroid responders.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the pre & post intraocular pressure status following Small incision lenticule extraction FEMTOLASIK & LASIK in presence of altered corneal thickness and biomechanics in Indian myopic eye.	1 week 4 week 8 week 12 week

Secondary Outcome Measures

Name	Time	Method
To establish a nomogram to correlate between apparent & real intraocular pressure using CORVIS ST NONCONTACT TONOMETER APPLANATION TONOMETER & to use most suitable method to evaluate intraocular pressure in post refractive eyes	1 year

Trial Locations

Locations (1)

Centre For Sight; 🇮🇳 Delhi, DELHI, India

Centre For Sight

🇮🇳Delhi, DELHI, India

Dr Shiva Kushwah

Principal investigator

8989271707

shivakushwah22@gmail.com