Clinical Evaluation of the BunnyLens IOL

Transcription

1 Clinical Evaluation of the BunnyLens IOL Introduction: BunnyLens is a foldable Hydrophlic Acrylic IOL with four ear shaped haptic design. The lens design offers many advantages in terms of: 1. Centration and stability - 4 Contact points with the bag centration ensures centricity and long-term stability. 2. Ease of injection through a sub 2.5mm injector cartridge. 3. Predictability of refractive error correction. 4. Very low rate of posterior Capsular Opacification Square edge stepped barrier design reduced PCO (helps prevent cell migration onto the posterior capsule). 5. Excellent memory slow gentle release, superior foldability slow and gentle unfolding. Specifications: Overall length 11.0 mm [11.5 mm in +1.0 to +9.0 D.] Optic Diameter 6.0 mm Power range +1 to +7 (1.0 increments) +8 to +30 (0.5 increments) Optic design Equi -convex Lens design Square edge with stepped barrier Haptic angulation 5º Material Hydrophilic Acrylic UV blocker Refractive index (35º c) YAG laser Compatible A constant Placement Capsular bag 1

2 Methods: The study was a prospective, non-randomized, multi-center study. 84 subjects were operated by a one to two surgeons per site at each of the seven participating investigative sites (total eight surgeons 7 sites). Eyes included in this study were enrolled between June 2006 and July Table 1 below specifies the investigative sites, surgeons and number of subjects: Table 1: surgeons Medical center Number of Subjects Dr. E. Dahan Sandhurst eye center and Rosebank 20 Dr. Nady Clinic, Johannesburg South Africa Dr. Bukelman Assuta medical center, Rishon Israel 28 Prof. E. Assia Ein Tal medical center, Tel-Aviv Israel 11 Prof. H. Garzozi Bne-Zion medical center, Haifa Israel 7 Dr. Schwartz Rephael medical center, Tel-Aviv Israel 10 Dr. V. Bersodski Naharya medical center, Naharya Israel 3 Dr. Y. Lang Elisha medical center, Haifa Israel 5 Total 84 The BunnyLens IOL was implanted following cataract removal by phacoemulsification. Surgical complications, ease of IOL implantation and IOL location and centration were recorded at the end of each operation. Specific study visits were required at 1 day, 1 week, 1 month postoperatively. Postoperative procedures at each visit included measurements of visual acuity (VA), manifest refraction, intraocular pressure and slit lamp examination. These same tests were performed preoperatively along with any special measurements necessary for lens selection. An analysis of the following parameters was done: Operative Complications. IOL behavior during implantation. IOL location and Centration Postoperative Adverse Events. Postoperative Visual Acuity. Intraocular Pressure Changes. 2

3 Results: Intraoperative complications Three out of 84 IOL (represent 4%) was damage during the implantation (two IOL: broken haptic, one IOL: small tear on IOL central bump). The damage does not influence IOL location and centration. No other operative complications were reported in any of the operations. IOL behavior during implantation BunnyLens implantation was easily done utilizing injector throughout mm incision size. The implantation grades, given by the surgeons, presented in table 2: Table 2: Parameter Average Remarks Grade IOL Folding Easy BunnyLens folding defined as easy in 10 of the cases. IOL Inseration Easy BunnyLens insertion defined as easy in 10 of the cases. IOL Unfolding Smooth BunnyLens unfolding defined as smooth for all IOL, excluded 2 IOL with broken haptics. IOL Centration Good BunnyLens centration defined as good or perfect in 10 of the cases. IOL Haptics positions Bag / Bag BunnyLens haptics positions was Bag / Bag in 10 of the cases. IOL location and Centration One hundred percent of the lens was found to be located with 4 loops in the capsular bag. The BunnyLens demonstrated a good stability and centration from implantation throughout the one month follow-up period. Postoperative Complications There was no evidence of post operative infection or excessive inflammation in any of the patients. 3

4 Adverse Events: A summary of the adverse events occurring in the study compared to allowable rates for posterior chamber IOL as define by ISO provided in Table 3 below. Table 3: Adverse Event Allowable rate ISO ; 100 subjects BunnyLens N=84 Cystoid macular 6% oedema Hypopyon 1% Endophthalmitis (1) 1% Lens dislocation from 1% posterior chamber Pupillary block 1% Retinal detachment 1% Secondary Surgical 2% intervention (2) Persistent Corneal stroma oedema 1% Cystoid macular 2% oedema Iritis 1% Raised IOP req. treatment 2% (1) Endophthalmitis is defined as inflammatory reaction (sterile or infectious) involving the vitreous body. (2) Excludes posterior capsulotomies. As shown at table 3, Bunnylens demonstrate very good safety profile. 4

5 % of patients Postoperative Visual Acuity Preoperative visual acuity (VA) is summarized in Table 4. Postoperative visual acuity (VA) at 1 month is summarized in Table 5. Chart 1 provides VA data at preoperative, 1 day / week / month postoperative. As shown in table 5, postoperative VA of 6/12 or better was reported at 1month in 90 % of all eyes. Of the 8 eyes that did not achieve 6/12 or better VA, 6 had reported preoperative ocular pathology (4 AMD, 1 sever DR, 1 Corneal opacity). Table 4: Preoperative VA Table 5: 1 Month Postoperative VA % of patients % of patients 6/12 or better 24% 6/6 38% 6/15 or better 36% 6/9 or better 8 6/30 or better 72% 6/12 or better 9 6/60 or better 81% Worse than 6/12 1 Worse than 6/120 19% Average VA 6/9 Chart 1: 45% 4 35% 3 25% 33% Visual Acuity 42% 38% 33% 36% 29% 2 15% 1 5% 1% 16% 6/6 7% 6/9 16% 17% 16% 6/12 12% 1 1 9% 5% 6/15 19% 14% 12% 9% 6% 1% 1% 3% 6/30 6/60 3% 1%1% 6/120 Pre op. VA 1 day VA 1 week VA 1 month VA BunnyLens provides excellent optical performances as shown above (average: 6/34 vs. 6/9 Pre-op vs. 1 month Post-op VA respectively). Comparison of BCVA results to ISO criteria: A comparison of the results at 1 month versus target best corrected visual acuity (BCVA) criteria (from ISO :2006) is provided in Table 6 below. Table 6: BCVA 6/12 or better Target criteria (ISO : subjects) 5 Bunny Lens IOL (At 1 month post op.) Overall subjects (1) N= 79 88% 9 Best case (2) N=73 94% 97% (1) For all subjects with available BCVA data. (2) Subjects with preoperative ocular pathology (excluding cataract)

6 % patients Intraocular Pressure Changes: Changes in intraocular pressure (IOP) from the preoperative versus the 1week and 1month postoperative visit are summarized in Table 7 and chart 2 below. Only one eye reported an increase in IOP of greater that 5mm Hg at the 1 week postoperative visit, at 1 month visit IOP increment was not greater then 1mm Hg. The majority of the eyes (59 %) reported a slight decrease (1mm Hg) or no change, at 1 month postoperative. Table 7: IOP (mmhg) % of patients at 1 week visit % of patients at 1 month visit Decrease 4 to 8 29% 31% Decrease 1 to 3 42% 37% No change 21% 22% Increase 1 to 2 2% 1 Increase 4 to 8 6% IOP Mean Change (mmhg) 2.5 (mmhg) 2 (mmhg) IOP Change Range (mmhg) +8 to -7 (mmhg) +1 to -8 (mmhg) IOP Mean (mmhg) 13 (mmhg) 13 (mmhg) IOP Range (mmhg) 9-22 (mmhg) 8-18 (mmhg) Chart 2: Intraocular Pressure 45% 4 35% 3 25% 2 15% 1 5% 42% 37% 29% 31% 21% 22% 1 6% 2% 4 to 8 Increase 1 to 2 Increase No change 1 to 3 Decrease 4 to 8 Decrease IOP change (mmhg) 1 week change 1 month change 6

7 Conclusions: BunnyLens is an acrylic IOL with a four ear shaped haptic. The data from this study were compared to ISO :2006 criteria, the data exceeded the visual acuity criteria and adverse events were within allowable rates. No operative complications were reported with subjects enrolled in this trial. The detailed data from the current study on 84 eyes show unequivocal benefits from this new design of IOL: Bunny Lens performances (BCVA and safety profile), are within ISO :2006 criteria. Excellent optical performances. Very good IOL behavior during implantation. Perfect IOL centration. Very good safety profile as reflected from: intra and post operative complications, intraocular pressure changes, and posterior capsule opacification at 1 month. The data from the current study, suggest that the Bunny Lens can be used safely and effectively for the treatment of aphakia following cataract extraction. 7