Treatment for nearsightedness
- Conditions
- Health Condition 1: H521- Myopia
- Registration Number
- CTRI/2020/07/026735
- Lead Sponsor
- Alcon laboratories India pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Subject must be able to understand and sign an IRB/IEC approved Informed Consent form.
- Willing and able to attend all scheduled study visits as required per protocol
- Myopia with sphere of -0.50 to -10.0 D cylinder <1.00 D (MRSE within -0.50 to -10.0 D)
- Other protocol defined inclusion criteria may apply
- Women of childbearing potential, defined as all women who are physiologically capable of becoming pregnant and who are not postmenopausal for at least 1 year or are less than 6 weeks since sterilization, are excluded from participation if any of the following apply:
a. they are currently pregnant,
b. have a positive UPT result at Screening,
c. intend to become pregnant during the study period,
d. are breast-feeding.
Subjects who become pregnant during the study will not be discontinued; however, data will be excluded from the effectiveness analyses because pregnancy can alter refraction and visual acuity results
- Study eye unable to focus for imaging and/or treatment
- Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study as clinically assessed by the Investigator (including history
of Herpes Simplex)
- Current use of medications with known ocular side effects and photosensitivity, including but not limited to: steroids, antimetabolites, Isotretinoin (Accutane®), Amiodarone hydrochloride (Cordarone),or Hydroxychloroquine (Plaquenil), Tetracyclincs, Nalidixic Acids, and Fluoroquinolones
- Other protocol specified exclusion criteria may apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Extraction of lenticule <br/ ><br>(-0.5 to -10.0 D) <br/ ><br> <br/ ><br>2. Presence of optical treatment zone corneal haze (slit-lamp examination) <br/ ><br> <br/ ><br>3. Change in ECD between pre-op and post-op <br/ ><br> <br/ ><br>4. Presence of Lens Opacification (slit-lamp examination) <br/ ><br> <br/ ><br>5. Presence of disruption in the integrity of retinal layers (OCT) <br/ ><br>Timepoint: 1. At Surgery visit <br/ ><br> <br/ ><br> <br/ ><br>2. At 1 month and 6 months <br/ ><br> <br/ ><br> <br/ ><br>3. At 1 month and 6 months <br/ ><br> <br/ ><br>4. At 1 month and 6 months <br/ ><br> <br/ ><br> <br/ ><br>5. At 1 month and 6 months
- Secondary Outcome Measures
Name Time Method ot applicableTimepoint: Not applicable