Severe unilateral congenital ptosis with poor levator function: tarsoconjunctival mullerectomy plus levator resection vs frontalis sling procedure

INTRODUCTION

Overcorrection is defined as MRD1≥3 mm and bilateral asymmetry ≥2 mm.

Modified maximal levator palpebrae superioris shortening was another effective and endurable route of treatment for sever congenital ptosis with poor LF especially in patients whose LF was less than 2 mm

.

尘世中的好男人，应该就是这个模样了吧。生而为人，谁还没几个缺点呢？毕竟你我，也只是许姣容那般的普通女子，求的是平安顺遂，要的是白头偕老，盼的是子孙满堂。完美太难得，幸福就很好。

The aim of the present study is to compare the functional and cosmetic outcomes, complications, and success rate of frontalis sling and TCMLR in subjects with severe unilateral congenital ptosis with poor LF.

为了取得一些准确数据，他们专门到北京、天津的有关单位查阅了大量的资料，成功地研制了用做防腐施工配套的吊管机。在防腐时，吊管机吊着管道在前面走，胶带缠绕机随后进行胶带缠绕，大大方便了施工操作，提高了工作效率。

SUBJECTS AND METHODS

First by anterior approach, the levator muscle was resected according to MRD1 and LF, afterward; the tarsus, conjunctiva and muller muscle were resected according to correction requirements of each patient adaptively (no Putterman clamp usage), adjustment suture of levator to the tarsus was performed with Vicryl 6-0, and then repair of tarsus to the conjunctiva was done with Vicryl 7-0.

哮喘急性发作时呼气流速指标急速下降，且哮喘患者多存在肺功能异常[15]。本研究结果显示，肺炎支原体肺炎患儿的通气功能障碍主要以限制性为主，通过治疗后其大通道通气指标(FVC、FEV1、PEF)均可恢复，且趋于正常，但对照组小通道通气指标(FEF25、FEF50、FEF75)改善不明显，观察组联合应该顺尔宁治疗后可有效改善肺功能，特别是对小气道通气指标的改善较为明显。同时，观察组临床疗效，咳嗽消失时间、喘息缓解时间、IgE减轻时间等临床症状改善均优于对照组，且两组均无明显不良反应。

The sample size was calculated by G power software (version 3.1), power=80%, α=5%. Totally, 50 participants with complete and full record of demographic, surgical, and postoperative parameters were recruited and comprised of two groups; the frontalis sling and TCMLR procedures (26

24 participants respectively).

All frontalis sling procedures were performed by single plastic surgeon (Jamshidian-Tehrani M) and all TCMLR procedures were accomplished by one another plastic surgeon (Kasaee A), each group was assigned according to the patient’s age,in which TCMLR was done for age range of 2-42y, and the frontalis sling procedure was performed for the age range 1-17y,and the criteria for selection of each group was the surgeon’s expertise, preference and his/her trends.

According to ethical considerations, the TCMLR procedure should be done in elderly participants because of tarsal growth in younger age and chance of cicatricial entropion in excessive removal of tarsus.

建立科学的教师专业标准是教师从一种“职业”成为一种“专业”的基本标志，是客观评价教育质量的依据[10]。然而，体育教育在整个教育领域中处于边缘地位，与其他学科的教师相比，体育教师似乎也低人一等。体育教师的专业发展的生涯始于进入大学的体育教育专业，但是，无论是职前的培养、毕业，还是新体育教师的准入、职后的培训，都处于“无章可循”的状态[11] 。因此，制定体育教师的专业标准迫在眉睫。在个体层面，职前、职后的专业标准为体育教师提供衡量自身专业水平的基本准则；在群体层面，专业标准形成体育教师之间专业对话的交流工具；在组织层面，为机构在选择、培训体育教师方面提供准则。

The inclusion criterion included patients with poor LF (4 mm and less) and severe unilateral congenital myogenic ptosis. Subjects who had poor bell’s phenomenon, cerebral palsy, previous surgical history and other causes of ptosis (blepharophimosis,Marcus Gunn Jaw Winking reflex,

.) were excluded.

Whitehouse

demonstrated retrospectively 80 eyelids with unilateral and bilateral congenital ptosis that underwent levator resection and frontalis sling surgery with fascia lata;21% and 4% of them required second and third surgery,respectively. They concluded that in patients with good LF,the levator muscle resection is recommended and in poor LF the frontalis sling is suggested. In comparison with the present study; we used a distensible material for the sling,and Whitehouse

used fascia lata, which is much more restrictive. One of the etiologies for the difference of success rate and complications in various materials of frontalis sling procedure is related to the mentioned etiology

.However, in the present study, no secondary corrective surgery was required for any of the patients, and we concluded that TCMLR results are similar with frontalis sling in severe unilateral congenital ptosis with poor LF.

A complete eye examination was performed with special attention given to the history, a detailed slit lamp examination,ocular surface test, fundus examination, detailed ptosis analysis(amount, type, severity), LF, bell’s phenomenon, visual acuity and refractive error assessment, extraocular movements,pupillary light reflex, marginal reflex distance1 (MRD1),MRD2, absence or presence of lid crease, palpebral fissure (PF)heights, eyelid excursion, and the head position (the variables in children younger than 5 years old, were approximately measured according to lack of cooperation).

The aforementioned variables LF, cosmetic outcomes (MRD1, MRD2, PF height) were evaluated preoperatively. The variables such as LF, cosmetic outcomes (MRD1, MRD2, PF height), complications[lagophthalmos, ocular surface changes (tear film profile),exposure keratopathy, punctate epithelial erosions (PEE),allergic reactions, overcorrection and under correction] and success rate were fully evaluated for these participants at 1,3, and 6mo postoperatively by Aliabadi M and was doublechecked by the assigned surgeon.

Surgical Techniques Description

The Ethics Committee of Tehran University of medical sciences approved the study protocol (IR.TUM.FARABIH.REC.1397.044). All procedures performed in studies involving human participants were in accordance with the ethical standards of the Institutional and/or National Research Committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.All eligible subjects’ or their parents agreed and signed the written informed consent after full explanation of the purpose and nature of all procedures used. The consent is obtained to publish identifiable photographs and is archived with the authors, although the authors cropped the clinical photographs that identifications is not possible. The RCT code of this study is IRCT20200613047753N1.

Suspension of frontalis muscle was performed with the pentagon technique

(5 incision,2 incision on eyelid crease

and 3 incision above the eyebrows)

by Crawford silicon rods (ECI, Louis Armand Co., Paris) and securing the knot with Vicryl 5-0

.

Definition of Terms

Graded as mild (≤2 mm), moderate (3 mm), or severe(≥4 mm) from the normal position of rest in primary gaze

.

MRD1≥3 mm, bilateral asymmetry <1 mm is defined as complete success rate, 2≤MRD1<3, 12 mm is defined as failure rate. Total success rate is summation of complete and incomplete success rate.

Severe unilateral congenital ptosis with poor levator function (LF) is the most challenging category of congenital ptosis varieties

.Frontalis sling is the choice procedure for congenital ptosis with poor LF, which could be performed by different materials such as silicone rod, sutures, frontalis muscle flap, temporalis fascia,fascia lata and

. Although unilateral ptosis frontalis sling surgery does not achieve perfect eyelid function and cosmetic appearance as well as bilateral ones

. Furthermore,frontalis suspension surgery has serious and common problems such as surgical failure, eyelid and brow asymmetry and lagophthalmos much more in unilateral cases

.Tarsoconjunctival mullerectomy plus levator resection(TCMLR) is considered as an alternative method to frontalis sling surgery, which is not discussed in the literature,attentionally its success rate, complications and comparison to frontalis sling procedure in the aforementioned ptosis category

.

民营企业的贡献，在民营企业家的心里最清楚。娃哈哈集团董事长宗庆后11月20日在“2018（第十六届）中国企业竞争力年会”上发言说，央企、国企主要是为强国而奋斗，民企应该是为富民而奋斗。他认为，国家要采取积极的财政政策，给企业降低税费，还要降低老百姓的个税，降低社保费率，让老百姓有钱去花，把内需拉起来，经济发展还是很好的。笔者认为，这是广大民营企业家的心声，体现了民营企业家朴素的财政观。

The success rate of two surgical procedures was compared at 1, 3, and 6mo (Table 3). Statistically significant difference of complete success rate was detected for the 1

and 6

month evaluation between two groups, indicating that the success rate of frontalis sling was higher in the 1

month, and vice versa at the last follow-up.

PF width measurement in closed eye.

Mild≤1/3 of corneal surface involvement, 1/32/3 of corneal surface involvement.

Ptosis, success rate, overcorrection, lid lag, lagophthalmos were measured and graded by measurement ruler, and PEE was evaluated by slit lamp examination and fluorescein staining.

To compare continuous variables between two groups of different surgical procedures,

-test was utilized,and for comparing discrete variables between two groups,Chi-squared and Fishers’ exact tests were the tools. Moreover,the nonparametric Mann-Whitney test was used to compare the distribution of non-normal variables, between two groups. The Kolmogorov-Smirnov Calculator (test of normality) was used to evaluate the distribution of data. The SPSS software(ver. 25) was used to analyze the data. The significance level was chosen to be 0.05.

RESULTS

Fifty patients with severe unilateral congenital ptosis with poor LF were enrolled in frontalis sling and TCMLR operations(26 and 24 patients respectively). The mean (SD) age was 10.97±10.67y (male/female ratio=35:15). The baseline characteristics and outcomes compared between frontalis sling and TCMLR groups in Table 1.

1.4 统计学分析 资料数据采用SPSS 22.0统计学软件进行分析，计量资料采用均数±标准差表示，进行t检验；计数资料采用例和百分比[例(%)]表示，进行χ2检验，P<0.05为差异有统计学意义。

根据稻曲病毒素容易附着在稻种表面的特性，在稻谷播种前，一定要对稻种进行适度紫外线高温或太阳紫外线杀菌处理，或者是用药剂消毒浸种，药剂可以选用强氯精消毒浸种，也可以选用石灰和多菌灵，或用50%甲基托布津可湿性粉剂500倍液浸种24 h，然后捞出催芽、播种。

LF, PF, MRD1, and MRD2 were measured at months 1, 3,and 6 for both procedures and described in Table 2. The LF was significantly more in the TCMLR group at months 1, 3,and 6, but no significant difference was observed for the other aforementioned outcomes.

The study was performed at Ophthalmic Plastic Unit, Farabi Eye Hospital, Tehran University of Medical Sciences (TUMS),Tehran, Iran. In this prospective non-randomized non-blinded clinical trial study, fifty patients (50 eyelids) with severe unilateral congenital ptosis with poor LF were enrolled, during 2018-2020.

The postoperative surgical complications such as ocular surface condition (tear film profile) and PEEs were measured between frontalis sling and TCMLR procedures at months 1, 3, and 6. Mild PEE was more observed in the 3

month evaluation on the frontalis sling group (16 frontalis sling

4 TCMLR;

-values of month 1, 3 and 6 were as follows: 0.56, 0.002, 0.05). Severe and moderate

PEEs were not found in any patient.

第三，进一步有效开发社区内教育资源。现有社区资源的有效利用能够更加快速有效地推进资源建设。从无到有是总量的增加，其附带的变化因素颇多，但是从有到精，充分利用已有资源来创造优良的教育环境，意义要大于前者。通过现有资源的变革和创新，教育模式的重构和整合，以挖潜、扩充的手段不断拓展资源容量，社区的教育会更加良性发展。

但这并不意味着龙套就不重要，更不是可有可无。将主角与龙套的关系比喻为红花与绿叶，很有道理。红花固然鲜艳夺目，如果少了绿叶扶持，赤裸裸的红花不仅显得形单影只，甚至给人流水飘零的感觉。陪伴的绿叶如果缺乏精气神，耷拉着、萎缩着，也给人花期将尽之感；绿叶春意盎然，红花才能显示勃勃生机。

Lagophthalmos ≥ 1 mm was more common in the TCMLR group in all three follow-ups, but the difference was not statistically significant [12, 12, 13 cases in TCMLR group and 11, 12, 11 cases in frontalis sling group in 1, 3, 6mo followups respectively (

=1)]. Furthermore, the lid lag > 3 mm was statistically similar in both groups [19, 19, 19 cases in TCMLR group and 21, 22, 22 cases in frontalis sling group in 1, 3, 6mo follow-ups respectively (

=1)].

PF width measurement in downgaze.

Total success rate of frontalis sling and TCMLR procedures were 65.3% and 79.1% respectively which is not statistically different (

=0.27). The success rates related were demonstrated in Figures 1-3. Incomplete success, failure rate and overcorrection were more detected in frontalis sling method without statistically significant difference. Asymmetric crease was observed in 15.5% of the frontalis sling and 12.5%of the TCMLR procedures (

=0.76). Allergic reaction and signs of extrusion were not happened in any patients of both groups.

In the Figures 2 and 3, the preoperative photographs of two unilateral congenital ptosis cases were presented, and the postoperative six months follow-up of two procedures (frontalis sling and TCMLR) were mentioned. In the section, the six months postoperative, lagophthalmos of two procedures were presented.

DISCUSSION

The aim of the present study is to compare the functional and cosmetic outcomes, complications, and success rate of frontalis sling and TCMLR in subjects with severe unilateral congenital ptosis with poor LF.

Preoperatively there was no significant difference in eyelid indicators such as LF, PF, MRD1, and MRD2. The mean age was lower in the frontalis sling group than in the TCMLR similar to Whitehouse

mean age. The mean age of Kabra and Khatri’s study

was 15.85y. The etiology of late age diagnosis in the present study and the other studies is the lack of awareness about the possible visual and fascial cosmetic abnormalities associated with ptosis and the disability to describe the complications in children and incomplete growth of the tarsus make the surgeons to prefer frontalis sling instead of TCMLR in children group. Subsequently, the assigned surgeons elected to have TCMLR in older children to find more defined eyelid structures.

在现代信息技术的促进和发展下，文化创意产业的共享和社交属性被进一步的放大。但是，在实际对文化创意产业集聚区的建设过程中，场域内的社交功能往往被区域建造所忽略。根据雅各布斯的研究，只有“地点靠近社会和功能的多元化和活跃性都突出的地区，才能自然地、随意的受到人们的享用”[6]。因此，在未来的城市空间重构中，要对空间的“社交”属性进一步思考。

The results show that TCMLR, in terms of eyelid position indicators and postoperative complications, is well comparable to the standard frontalis sling method.

糖蜜酸化液：80 g糖蜜加120 mL蒸馏水搅拌均匀，用硫酸调节pH 4.0～4.3，90～95 ℃水浴并不断搅拌15 min，4000 r/min离心10 min，取上清。

Prior to the operation, neither group had lagophthalmos, but in all three follow-ups, more patients of the TCMLR group had lagophthalmos, although the difference between two groups was not statistically significant, it might be according to tarsal plate shortening in the TCMLR procedure. A significant point of the present study was the increment of levator muscle function in all three follow-ups of TCMLR. This finding can be justified by the association of levator resection or its strengthening in this group. None of the three variables (MRD1,MRD2, and PF) were significantly different in three followups between two studied groups. As a result, the appearance of the eyelids is comparable to any of the frontalis sling and TCMLR. Nearly 80% of both groups had lid lag during the study, there was no significant difference between two groups regarding lid lag. It is important that the lack of difference in the above parameters does not necessarily mean that there is no difference in appearance and cosmetic results. The frontalis sling surgery’s complications could be mentioned as; skin scars may remain at the incision sites just above the eyebrows or unequal eyebrow elevation, and asymmetric crease.

Corneal erosion or dry eye was significantly different in 3mo follow-up between two groups which mentioned by higher rates of corneal erosion in frontalis sling group. No significant differences were detected for the mentioned complications in the first and 6mo follow-up. Our interpretation for the mentioned significant complication in the frontalis sling group at the 3

month could be multifactorial which is dependent to maternal care, drug compliance and surgical technique.

In the first month, the complete success rate of frontalis sling group was significantly higher than the TCMLR group which was inversed in the 6

month.

Kabra and Khatri’s

reported the results of various surgeries on 52 eyelids with congenital ptosis with a follow-up period of 1,3, and 6mo. They performed TCMLR for the patients with good LF and mild ptosis and considered frontalis sling surgery for the patients with weak LF and severe ptosis. At the end of study,no significant difference was reported between two surgeries in terms of cosmetic and functional outcomes, although complications were greater in the frontalis sling group. Good LF selection for TCMLR procedure in Kabra and Khatri’s

study may explain the difference with the present study.

In the present study, no significant visual complications were observed in any of the studied groups.

A single trained ophthalmologist (Aliabadi M) performed detailed history and physical examination, and extracted clinical parameters and anthropometric variables, through hospital charts and face-to-face interviews in the first and the following preoperative and postoperative visits.

Pang

retrospectively examined the indications, efficacy,and postoperative complications of Fasanella-Servat surgery to treat mild to moderate ptosis with a variety of underlying causes,in contrast of our prospective study for the severe congenital cases. The best results were achieved in patients with Horner syndrome (100% success) and in patients with previous levator resection (100% success) although the unsatisfactory results were demonstrated in congenital ptosis (76.4%). The lowest success rate of Pang

’s

study was achieved in congenital ptosis which is comparable with the present study (65.3%),although the population selection (first operation

reoperation) and the procedures are differed between two studies. Levator muscle was resected in TCMLR method that is less compromised in Fasanella-Servat surgery.

However, in the present study, the surgical results for severe ptosis with poor LF were also desirable and recommended.

电机本体中气隙合成磁动势是由电枢磁动势与转子励磁磁动势所合成，与气隙合成磁动势对应的磁通链在本文中称为定子磁链。

Nucci

with 5y follow-up after silicone rod frontalis sling surgery, in 20 children with severe unilateral congenital ptosis with poor LF reported the increment of MRD1 postop., but no change of this indicator in 12mo and 5y follow-up (90%success rate), which is 65.3% in our frontalis sling group with six months follow-up.

The success rate of silicone frontalis sling method in congenital ptosis with poor LF was 90.9% in 6mo follow-up of Tabatabaie

’s

study, that the differences with the present study was the ptosis severity and population selection.

The results of unilateral frontalis sling surgery were satisfactory in patients with conscious active unilateral brow elevation which is challenging in children

. These results could be so unsatisfactory according to children’s disability to elevate one eyebrow. Furthermore, severe congenital unilateral ptosis subjects with amblyopia usually require conscious effort to activate the frontalis muscle to achieve satisfactory eyelid height, so they are the most challenging casess

.

Unilateral frontalis sling provides good to excellent functional and cosmetic results in unilateral poor LF ptosis however, their study group was compromised of congenital, posttraumatic and jaw-winking ptosis

. In comparison with the present study, the merely difference was direct suturing of frontalis sling to the tarsus.

Conclusively, some studies recommended bilateral levator muscle cutting and bilateral frontalis sling procedure for the unilateral congenital ptosis with poor LF

, whereas;these controversies is not present in bilateral congenital ptosis with poor LF. The positive point of the present study is to recommend another alternate procedure for severe unilateral congenital ptosis with poor LF. So according to ethical considerations, the authors performed TCMLR in elderly group. TCMLR could be suggested as an alternate procedure instead of frontalis sling method to correct severe unilateral congenital ptosis with poor LF. The TCMLR is more aggressive than frontalis sling method, so more edema was detected in short-term follow-up, which was removed in midterm and improved the success rate in contrast of frontalis sling method. We have a lower upper lid in the earlier postoperative measurements probably due to increased edema in that child case of TCMLR group. Incomplete success and a failure at the beginning of the observations probably can be also explained by the edema. Proper growth of the tarsus had morally limited us to TCMLR surgery at a higher average age because their tarsus had grown enough. TCMLR could be suggested to correct the aforementioned condition in elderly patients while frontalis sling is suggested for the young.

Hence, future studies might compare the aforementioned procedures in children group.

The different results and controversies may accord to different studies that we should determine the population selection,differences of population characteristics, sample sizes, study design, different age ranges, and evaluation period and follow-ups, inclusion/exclusion criteria, different health care strategies, different study protocols and highly selected and methodological shortcomings.

The strengths of the present study were that all measurements were performed in a referral ophthalmologic center. Furthermore,the study design was a prospective non-randomized clinical trial.The limitations of the present study were as follows; low prevalence of severe unilateral congenital ptosis with poor LF, small sample size, short follow-up duration, two surgeons by especial preferences and non-randomization method.Furthermore, due to ethical considerations, the TCMLR procedure should be done in elderly participants because of tarsal growth in younger age and chance of cicatricial entropion in excessive removal of tarsus; so, one of the limitations could be the high mean age of the TCMLR procedure in comparison of the frontalis sling group. Additionally, in TCMLR group,the amount of tarsus and levator resection was not measured and also a limitation for TCMLR is the possibility to develop dryness because of the partial resection of the accessory lacrimal glands and Meibomian glands as well.

In conclusion, complete success rate of TCMLR is higher in long-term follow-up in contrast with the higher success of frontalis sling in the short-term. Transient complications were more detected in mid-term follow-ups in both groups.TCMLR could be suggested as an alternate procedure instead of frontalis sling method to correct severe unilateral congenital ptosis with poor LF.

ACKNOWLEDGEMENTS

The authors wish to thank the staff and personnel, who greatly helped us to complete the project.

Supported by Tehran University of Medical Sciences (No.9511257008).

Kasaee A, None; Aliabadi M, None;Najafi L, None; Jamshidian-Tehrani M, None.

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