Comparison of two types of intraocular lenses meant for providing both distance and near vision after cataract surgery
- Conditions
- Health Condition 1: H259- Unspecified age-related cataract
- Registration Number
- CTRI/2023/12/060492
- Lead Sponsor
- Biotech Vision Care Pvt Ltd Ahmedabad India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Cataractous lens changes as demonstrated by best corrected
visual acuity of 20/40 or worse either with or without a glare
source present (e.g., Brightness Acuity Tester) or with significant
cataract-related visual symptoms.
2. Best corrected visual acuity to be better than 20/30 after cataract
removal and IOL implantation as estimated by potential acuity
meter (PAM) or surgeon estimation
3. Clear intraocular media other than cataract.
4. Given written informed consent by subject.
5. Subjects are willing and able to comply with schedule for follow up visits.
6. Subjects should be 22 years or older.
1. Systemic disease that could increase the operative risk or
confound the outcome.
2. Systemic medications that may confound the outcome or increase
the risk to the subject in the opinion of the investigator
(tamsulosin hydrochloride (Flomax) or other medications with
similar side effects (floppy iris syndrome)).
3. Ocular condition that may predispose for future complications.
4. Previous intraocular or corneal surgery that might confound the
outcome of the investigation or increase the risk to the subject.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Binocular Distance Corrected Intermediate Visual Acuity at <br/ ><br>66cm (DCIVA@66cm) under photopic light conditionsTimepoint: Pre-operative, 1-2days, 7-14 days, 30-60 days, 120-180 days, 330- <br/ ><br>420 days]
- Secondary Outcome Measures
Name Time Method 1) Uncorrected distance visual acuity (UCDVA) [photopic] <br/ ><br>2) Uncorrected intermediate visual acuity (UCIVA) [photopic] <br/ ><br>3) Best corrected distance visual acuity (BCDVA) [photopic] <br/ ><br>4) Uncorrected Near visual acuity (UCNVA) [photopic] <br/ ><br>5) Distance corrected Near visual acuity (DCNVA) [photopic] <br/ ><br>6) Distance-corrected intermediate visual acuity (DCIVA) <br/ ><br>[photopic] <br/ ><br>7) Low Contrast (10%) Distance Corrected Intermediate Visual <br/ ><br>Acuity [photopic] <br/ ><br>8) Low Contrast (10%) Best Corrected Intermediate Visual Acuity <br/ ><br>[photopic] <br/ ><br>9) Defocus curves monocular and binocular <br/ ><br>10) Manifest refraction <br/ ><br>11) Subject questionnaire <br/ ><br>12) Subject ocular and visual symptoms (non-directed questions) <br/ ><br>13) Rotational stability <br/ ><br>14) Spherical equivalent <br/ ><br>Timepoint: Pre-operative, 1-2days, 7-14 days, 30-60 days, 120-180 days, 330- <br/ ><br>420 days]