| Objective Part 11.To shorten the operation time and improve the intraoperative experience of patients with posterior chamber intraocular lens(Implantable Collamer Lens,ICL)implantation of phakic eyes,this study designed a modified single incision,non-OVD ICL implantation technique through manual anterior chamber irrigation,and compared it with traditional ICL implantation technique to understand the difference in operation time of this novel technique,at the same time,evaluate the safety of this novel technique.2.To identify the intraoperative experience of patients undergoing our modified manual irrigation ICL implantation technique by comparison with femtosecond laser small incision lens extraction(SMILE)through questionnaire survey,to understand patient’s intraoperative experience of the two surgical methods and evaluate the impact of the novel technique on the intraoperative experience of patients after shortening the operation time.Part 23.To explore the relevant influencing factors of the vault after ICL implantation,and to clarify the correlation between the iris concavity(IC)and excessively low vault(vault <100 μ m)after ICL implantation,so as to provide a new experimental basis for the selection of ICL size before surgery,and at the same time provide a guarantee for obtaining ideal vault and improving the operation safety after ICL implantation.MethodsPart 11.A prospective randomized controlled study was conducted,one hundred and sixty-five participants(165 eyes)who underwent posterior chamber ICL implantation in Changsha Aier Eye Hospital from May 2021 to August 2021 were included.Participants were randomly divided into experimental group and control group.The experimental group was the modified manual irrigation ICL technique group(n=82)which adopts a single corneal incision and implant the ICL lens through continuous anterior chamber manual irrigation with “a disposable sterile irrigator” to maintain the anterior chamber space and stability as well as replacing the injection of OVD(sodium hyaluronate).At the same time,the “disposable sterile irrigator” filled with 5ml normal balanced salt solution(BSS)was used to operate in the eye,positioning lens haptics and complete astigmatism alignment.The control group was the conventional ICL implantation technique group(n=83).A main corneal incision with a side port was used,the OVD(sodium hyaluronate)was injected for anterior chamber maintenance,the ICL lens was implanted,the position of the haptics was adjusted,and the OVD in the anterior chamber was washed out.parameters such as uncorrected visual acuity(UCVA),corneal endothelial cell density(ECD),intraocular pressure(IOP)and anterior chamber depth(ACD)etc.were collected before surgery,and time of surgery was recorded by one research team member using a stopwatch and special conditions during surgery were recorded by notes.Postoperative BCVA,ECD,IOP,ACD and vault etc.at 2 hours,1 day,1 week,2 weeks,1 month and 3 months after surgery were evaluated during follow-ups.Surgical time difference between the two groups and safety of the modified technique was evaluated through comparisons between the two groups.2.Considering that SMILE is a surgical method with good patient experience and satisfaction among myopia correction surgery,after the completion of the first part of the randomized controlled study,patients intraoperative experience of the modified manual irrigation ICL technique was investigated through its comparison with that of SMILE.The surgical experience model was used as the theoretical framework to construct the patient surgical experience questionnaire.The questionnaire items were initially prepared through theoretical guidance,literature reference and brainstorming.The revised version of the questionnaire was formed through expert consultation and the patient pre survey was carried out.Content validity analysis is conducted according to the correlation points scored by the experts on the items of the questionnaire scale and the survey content.Factor analysis is used to evaluate the constructive validity of the scale.The reliability of the questionnaire was measured by using Cronbach coefficient and split half reliability.The final formal questionnaire is formed according to the test results.A questionnaire survey of intraoperative experience was administered 2 hours after the operation.By comparing the length of operation time,subscale scores and scores of each item of the questionnaire between patients from the modified manual irrigation ICL implantation group and SMILE,the impact of the modified manual irrigation method of ICL implantation with shortened surgical time on the patients’ sense of experience during the operation was analyzed.Part 2 3.A retrospective case-control study was conducted,the clinical data of 81 eyes from 2080 patients who underwent ICL V4 c implantation in Changsha Aier Eye Hospital from January 2020 to February 2022 were collected.Twenty-seven eyes of 27 patients with excessively low vault(< 100 μm)were selected as the case group(excessively low vault group).Fifty-five patients with vault(250 to 750 μm)including 23 males and 58 females constituted optimal vault group by matching anterior chamber depth,white-to-white distance and ICL size with cases with excessive low vault(< 100 μm)at a proportion of 1:2.The preoperative refractive power,anterior chamber depth(ACD),intraocular pressure(IOP),white to white distance(WTW),corneal thickness(CT),corneal curvature,pupil size and postoperative vault were collected.Anterior segment optical coherence tomography(AS-OCT)was used to observe the anterior segment structure and measure iris morphological parameters,including anterior chamber width(ACW),crystalline lens rise(CLR),iris concavity(IC),Iris thickness at the point 750 μm away from sclera spur(IT750)and ratio of iris concavity to iris length(ICR).Multivariate linear regression analysis was used to evaluate the correlation between postoperative vault and preoperative parameters and conditional logistic regression analysis was used to evaluate the risk factors of low postoperative arch height(vault <100 μm).4.Statistical analyses were performed by using SPSS 25.0 software(IBM Corp.,Armonk,NY,USA).The general demographic data of the subjects were described by frequency,constituent ratio,mean ± standard deviation or median,etc.Shapiro Wilk test was used to test the normality of experimental data.Two independent samples t-test or repeated measurement ANOVA were used for the comparison between groups and each time point within the group of measurement data with normal distribution.Mann Whitney U test or Kruskal Wallis test was used for the comparison between groups of grade data,and nonparametric tests test was used for the analysis of skewed distributed data.The critical ratio method was used for item analysis of the questionnaire scale,and the content validity and constructive validity were used to test the validity of the scale.Cronbach’s α coefficient and split half reliability was adopted for scale reliability.The independent sample t-test was used to compare the results of each item in the scale between the modified ICL implantation group and SMILE.Pearson correlation coefficient or chi square test were used to determine the correlation of age,sex,picture selection to the scoring results of the scale.Univariate covariance analysis was used to control the confounding factors,and the scale scores of the two groups of patients were compared.Multivariate linear regression analysis was used to evaluate the relationship between the postoperative vault and various variables,and conditional logistic regression analysis was used to evaluate the risk factors of low postoperative vault(vault <100 μm).P-value < 0.05 was considered statistically significant.Results Part 11.Safety and surgical time of modified ICL implantation through manual irrigation method: Among 165 myopic participants with ICL implantation,one subjects in the manual irrigation group(MI group)and in the conventional method group(OVD group)respectively withdrew due to personal reasons.In the conventional method group,one subject withdrew from the follow-up process because of studying abroad.The final effective cases were 162 cases(162 eyes),81 cases(81 eyes)in each group.The surgical time of the single incision OVD-free approach of the modified manual irrigation group was(112.93 ± 103.37 s),which was remarkably shorter than that of the conventional surgery group(425.36 ± 130.50 s),difference was statistically significant(P<0.001).Through the implementation of manual irrigation manipulation,59 cases(72.8%)of this group had all four haptics of ICL lens naturally slid to the back of the iris without any position adjustment right after the lens unfolded in the anterior chamber.12 eyes(14.8%)had 3 haptics naturally slid to the back of the iris;7 eyes(8.6%)had 2,and 2 cases(2.4%)had one haptic naturally slid behind the iris;In another 2 eyes(2.4%),4 haptics were remained on the iris surface during the lens unfolding.The operation time of these 2 cases were 321 seconds and 280 seconds respectively.In the MI group,the positioning of the haptics located on the iris surface was adjusted as follows: the 5ml BSS filled disposable irrigator with a bent-shaped blunt-end needle was used for continuous manual irrigation,the ICL haptics were successively adjusted to the ciliary sulcus through the rotation and push movement of the irrigation needle while maintaining the stability of the anterior chamber.On the contrary,all cases(100%)of the control group required the surgeon to use surgical instruments during ICL implantation to adjust the four haptics of ICL to the ciliary sulcus at the posterior chamber when the anterior chamber was filled with OVD.The ECD was 2981.49±221.46 cell/mm2,2968.27±226.04 cell/mm2,2980.20±226.81 cell/mm 2,2960.90±217.01 cell/mm2 respectively at 1d,2 w,1 m and 3 m after surgery of MI group,and was 2961.02±251.45 cell/mm2,2949.91±224.05 cell/mm2,2939.70±211.95 cell/mm2,2942.12±211.93 cell/mm2 respectively in the control group.There was no significant difference within each group at all time points before and after surgery and between the two groups at all time points after surgery(P > 0.05).Except for few individual transient elevations,the IOP level of participants in both MI group and control at all observation point was within the normal range.Except that the IOP at post operative 2-hour(16.93 ± 4.29 mm Hg)was higher than pre operation(P < 0.001)and post operative 1 day level(P < 0.001),IOP at other observation points was stable(P > 0.05).In conventional group,IOP fluctuated notably: changes were significant between pre-operative level with post operative 2-hour(17.39 ± 6.25 mm Hg,P = 0.001),1 day’s(13.99 ± 2.79 mm Hg,P =0.006),and 1 month’s level(13.94 ± 2.38 mm Hg,P = 0.046);significant differences were also found in IOP between post operative 2-hour and 1 day(P < 0.001),post operative 2 weeks and 1 month(P = 0.029),and post operative 1 month and 3 months(P = 0.043).Transient elevation of IOP occurred in 21 cases at post operative 2-hour,including 10 cases in MI group(12.3%,8 cases of mild elevation and 2 cases of moderate elevation),and 11 cases in control group(13.6%,3 cases of mild elevation,3 cases of moderate elevation and 5 cases of severe elevation).The postoperative vault of the two groups along the time course were within the normal range.Vault of the MI group at the time points 2 hours,1 d,1 w,2 w,1 m and 3 m after surgery were 0.52 ± 0.28 mm,0.50 ± 0.2 mm,0.49 ± 0.21 mm,0.49 ± 0.23 mm,0.46 ± 0.21 mm,0.51 ± 0.35 mm,and were 0.44±0.26 mm,0.45±0.19 mm,0.47±0.27 mm,0.45±0.19 mm,0.44±0.19 mm,0.44±0.17 mm respectively in the conventional group.UDVA of patients in the two groups at 1 month and 3 months after operation was significantly improved compared with that before surgery(P < 0.05).UDVA in the MI group at 1 month and 3 months after surgery were-0.0469 ± 0.0807 Log MAR,-0.0519 ±0.0673 Log MAR respectively and UDVA of patients in control group at 1 month and 3 months after surgery was-0.0494 ± 0.0793 Log MAR and-0.0531 ± 0.0672 Log MAR respectively.There was no significant difference between the two groups(P1m = 0.935,P3m= 0.910).No surgical related complications such as corneal edema,glaucoma,lens opacity and endophthalmitis during and after surgery in both groups occurred along the entire observation period.2.In the first part of this study,we explored that the operation time of the MI surgical method was significantly shorter than that of the conventional one.For patients with myopia correction surgery,whether the reduced surgical time has an influence on patient’s experience during surgery needs exploration.Therefore,we compared the intraoperative experience of participants with that of SMILE which had a high patents’ intraoperative satisfaction.After literature review,brainstorming and expert correspondence,our research team formed a pre questionnaire containing a psychological picture and a 15-item scale.The psychological image was used to understand the psychological state of the investigated patients while they were answering the questionnaire.The scale was used to evaluate the patients’ experience for surgery.Three hundred eighty-six questionnaires were distributed in the pre survey,292 valid questionnaires were collected with the effective recovery rate of 75.6%.Through item analysis,no statistically significance was found in the scores of Item 4(t =-1.899,P = 0.06)and Item 6(t =-1.416,P = 0.159),thus the two items were eliminated.The results of content validity showed that the I-CVI of the remaining 13 items was 0.83~1.00,and the S-CVI was 0.99,indicating a good content validity.After three rounds of factor analysis for constructive validity evaluation,items 3,5,12 and 15 were eliminated,leaving 9 items remained.Two common factors(subscales)were extracted with the cumulative variance contribution rate being 53.145%.The factor loading of the 9 remaining items ranged from 0.626 to 0.812.The common factors(subscales)extracted could effectively reflect all items;Items 1,2,13 and 14 formed the first subscale(patient’s self-feeling),and items 7,8,9,10 and 11 constructed the second(surgical procedure perception).The formal questionnaire was formed consisting one psychological picture and a 9-item scale in 2 subscales with 2 positive questions and 7 negative questions.The Cronbach’s Alpha of the scale was 0.730,the questionnaire was reliable.A total of 438 valid questionnaires were collected from the formal survey,including 182 in the MI-ICL group and 256 in the SMILE group.The age of the patient and the psychological state reflected by the selection of psychological pictures were correlated to the results of the scale.According to the results of image selection,in the MI-ICL group,there were significant differences(P < 0.05)in the score of Q1,Q2,Q5,Q8,Q9,total score and subscale 1 among different mental states of A “calm”,B “anxious”,C “stressed” and D “frustrated”,while in SMILE group,differences were significant(P < 0.05)in the score of Q4,Q6,Q7,Q8 and Q9,total score and both subscales among the above 4 substates.After correcting the two confounding factors of age and psychological state,there was no significant difference between the two groups in the total score(P = 0.191)of the scale and Q1(sense of pain,P = 0.118),indicating difference in the sense of pain was not significant between the two groups during surgery.The scores of Q2,Q3,Q7,Q8,Q9 in the MI-ICL group were lower than those in control group(PQ2 = 0.001,PQ3= 0.009,PQ7 = 0.018,PQ8 < 0.001,PQ9 = 0.07),and MI-ICL group was better than SMILE in subscale 1(self-feeling of patients’ surgical experience,P < 0.001);In contrast,patients in SMILE group had better perception of operational environment as compared in Q4,Q5 and Q6(PQ4 < 0.001,PQ5 = 0.002,PQ6 < 0.001).The results of SMILE group in subscale 2(surgical procedure perception)were better than those of MI-ICL group(P = 0.020).Part 2 3.There was no significant difference in age,refractive power,ACD,IOP,WTW,ACW,CT,pupil diameter and corneal curvature between the two groups(P > 0.05).However,the difference of CLR,IC and ICR of the lens in the excessively low vault group and the normal vault group were statistically significant(P < 0.05).Compared with the normal vault group,the excessively low vault group has a higher CLR.At the same time,among the relevant iris morphological indexes measured by AS-OCT,the iris concavity(P< 0.001)and ICR(P < 0.001)in the excessively low vault group were higher than those in the normal vault group.Multivariate linear regression analysis showed that the postoperative vault was correlated with the preoperative pupil diameter,CLR,iris concavity and ICR(P < 0.05).Conditional logistic regression analysis showed that iris concavity was an independent risk factor for predicting postoperative excessively low vault(OR=81.10;95% CI=2.87-2296.58;P = 0.01).Conclusions Part 11.Compared with the conventional ICL implantation technique,the modified manual irrigation technique adopts the method of using “a disposable sterile irrigator” to maintain the anterior chamber stability and to adjust the position of ICL,can significantly shorten operation time.At the same time,this novel technique achieves good safety and effectiveness.2.Compared with the intraoperative experience of SMILE patients,this novel ICL implantation technique achieves same level of intraoperative experience as SMILE,especially in the sense of patients’ self-feeling.Part 2 3.The vault after ICL implantation is correlated with pre-operative pupil diameter,CLR,iris concavity and the ratio of iris concavity to iris length(ICR),among which iris concavity is an independent risk factor for predicting low vault after surgery.The more obvious the iris concavity is,the higher the risk of low vault after ICL implantation.Therefore,paying attention to the iris morphology before operation is helpful to the proper selection of ICL size,and provides a novel thought for obtaining ideal vault postoperatively and improving surgical safety. |
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