Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO

Phase I — The duration of the study was one year

Primary Endpoint:  To Assess the intraoperative Safety and Performance of the Hydrophobic acrylic foldable Intraocular lens (IOL).

Secondary Endpoint: To determine the presence of lens related adverse events/residual risks in the individuals on whom the devices were implanted. 

Sample Size for Phase I: 150 subjects were recruited in India.

Overall, 150 eyes were implanted with Hydrophobic acrylic foldable Intraocular lens (IOL) – Monofocal.  

Among 150 eyes, 101 were female and 49 were male. The population at risk for developing visually-disabling cataracts and needing cataract surgery is typically the elderly. Out of 150 eyes, two were dropped out due to lost to follow up in Visit 3 (Day 60). 

There was an improvement in Uncorrected Distance Visual Acuity and Best Corrected Distance Visual Acuity of the eyes after the implantation of Hydrophobic acrylic foldable Intraocular lens (IOL) – Monofocal. There was an improvement in the clarity of vision at a distance with the implantation of Hydrophobic foldable Intra Ocular Lens without the use of glasses or contact lenses. Good patient satisfaction was shown in quality of vision. 

The curvature of the anterior surface of the cornea was not affected by insertion of IOL. 

IOL Decentration, IOL tilt, IOL discoloration and IOL opacity were not observed. Hydrophobic acrylic foldable Intraocular lens (IOL) - Monofocal have not caused any negative impact on visual performance by inducing optical aberrations and decreasing visual acuity and it does not cause any significant deterioration of visual performance and there was no requirement of IOL exchange. 

The normal range for IOP is between 10 and 21mmHg. It has been observed that IOP remained within the normal range after the implantation of Hydrophobic foldable Intra Ocular Lens, hence proving the product safety and efficacy. 

The analysis of safety parameter was based on adverse event rates compared to historical controls, specifically the FDA "Grid" of cataract surgery results. The adverse event rate was lower than FDA historic control grids. There were no safety related complications after the implantation of Hydrophobic foldable Intra Ocular Lens, which proves the safety of using our device. 

None of the eyes participating in the study had experienced any safety issues related to eyes and benefitted after using the Hydrophobic acrylic foldable Intraocular lens (IOL) - Monofocal which shows the safety of using the device on the eyes. 

The incidence of cumulative adverse events for the Hydrophobic acrylic foldable Intraocular lens (IOL) - Monofocal compared favorably to the FDA historical grid rates. No occurrences of cumulative adverse events were observed in any patients implanted with the Hydrophobic acrylic foldable Intraocular lens (IOL) – Monofocal. 

The incidence of persistent adverse events for the Hydrophobic acrylic foldable Intraocular lens (IOL) - Monofocal compared favorably to the FDA historical grid rates. No occurrences of persistent adverse events were observed in any patients implanted with the Hydrophobic acrylic foldable Intraocular lens (IOL) – Monofocal. 

There was no requirement of exchanging, removing or repositioning of IOL. 

In all the eyes implanted with IOL, no residual risks were observed. The Hydrophobic acrylic foldable Intraocular lens (IOL) – Monofocal restore the sight of the eye which was previously obstructed by a cataractous lens. The benefits of use of the lens for the target population outweigh the risk when used as indicated in accordance with the directions for use.