Tóm tắt Luận án Researching the effectiveness of lengthening levator muscle surgery to treat moderate and severe eyelid retraction

SPSS 15.0 software. 2.2.4 Research facilities * Equipment for examination: Snellen vision table, millimeter measure, Hertel proptosis ruler, eye examination microscopy, ophthalmoscope, Volk ophthalmoscopes, cameras, medical records. * Surgical equipment: Eyelid surgery kits, bipole electric burners, surgical microscopes, shock-proof kits. 2.2.5 Research process 2.2.5.1 Medical inquiry - Acquiring general information: Name, age, gender, address, phone number, occupation. - Acquiring functional symptoms information: blurred vision, aches and pains, red eyes, watery eyes, dizziness, double vision...Asking about medical history (trauma, Basedow, congenital, idiopathic ...), history of treatment, stable duration of disease. Preoperative photography. 2.2.5.2 Physical examination - Measure eyesight and vision correction using Snellen vision board (classified by the World Health Organization) - Visual acuity classification (20/20 - 20/70, 20 / 80–20 / 200, 20/400 – CF 1 m) - Assessing the condition of the eyeball: conjunctiva, cornea, eye fundus, mobility - Assess eyelid condition and compare 2 sides based on the following indicators: 8 + MRD1: Measure the distance from the pupil's reflected light to the eyelid margin at 12 o'clock in a straight looking position. + MRD1 difference (MRD1) = MRD1 (UER eye) - MRD1 (normal eye). Or if the other eye is abnormal:  MRD1 = MRD1 (UER eye) – 3,5 mm + Palpebral fissure height_ PFH : The height of the skin crease is measured from the midpoint of the free margin of the upper eyelid to the midpoint of the free margin of the lower eyelid. + PFH difference (PFH): PFH = PFH (UER eye) – PFH (normal eye). Or if the other eye is abnormal:  PFH = PFH (UER eye) – 10 + Skin crease height assessment (SC): The height of the crease is measured from the free margin of the eyelids to the crease when the eye looks downwards. + Skin crease difference: ( SC) = SC (normal eye) – SC (UER eye) + Curvature assessment (C): This index is measured by the distance from the highest point of the upper eyelid margin to the center point between the eyelid and the center of the cornea. + Sclera show assessment: sclera show index is calculated from the edge of the cornea to upper eyelid margin at 12 o'clock when the eyes are in a straight looking position. + Lagophthalmos assessment: Ask the patient to close his eyes to sleep gently and assess whether the eyelids are completely closed. + Lid lag (loss of synergy between eyelid and eyeball): Lid lag is calculated by the difference of the MRD1 in the downward and straight looking positions. + Proptosis assessment: The Hertel ruler is placed parallel to the plane across the 2 cornea vertices allows the measurement of the proptosis. + Difference proptosis:  proptosis = UER eye's proptosis - normal eye's proptosis +Levator function assessment (LF): Use a millimeter ruler to measure the amplitude of the movement of the upper eyelid in the center when maximally looking down and maximally looking up as the forehead muscle has been blocked at the reflection in the pupil at 12 o'clock when the eye is fully downward-looking. + Assess position of retraction: medial 1/3, center 1/3, lateral 1/3 2.2.5.3 Subclinical - CT scan to determine the mobility condition and the nerve condition. - Tests to evaluate thyroid function: FT3, FT4, TSH, TrAb, thyroid ultrasound. - General tests prepared for surgery. 9 2.2.5.4 Surgery * Surgical steps The steps are as follows: - Posture of the patient: Lying on the back, disinfected, lying on surgical towels which allows to sit up, local anesthesia with Dicain solution. - Mark the skin incision on the expected skin crease or under the crease of the opposite eye. For cases where the 2 eyes do not have creases, the height of the crease is expected based on the standard Asian creases (5-7 mm). If the patient has retraction in both eyes and needs surgery for both eyes, the incision of the skin crease can be used according to the old skin creases. - Local anesthetic under the eyelids with a 2% Lidocaine solution mixed with Epinephrine 1: 100,000. - Incise the skin with knife number 15 with the length of skin incision from 25 - 30 mm. Hemostasis under the skin. - The anatomy reveals and separates the septum of the levator muscle from the orbicularis ocular muscle and the tarsal. Continue to separate the levator muscle from the conjunctiva and remove the Muller's muscle. - From the position of the skin incision, surgery up to 5 mm to reach the orbital septum. From here, we need to dissect the orbital septum and turn over the flap by 180 degree so that the edge the flap goes down and connected to the levator muscle. The width of the orbital septum flap is fixed based on the length of the upper eyelid tarsal with a size of about 20 mm. However, the height of the flap of the orbital septum can be adjusted according to the degree of eyelid retraction - Exposure the lateral horn of the levator muscle and cutting off the lateral horn. - Suture fix the edge of the orbital septum flap to the edge of tarsal with 3 Vicryl 6.0 stitches. - Sit the patient up, evaluate the height and curvature of the upper eyelid. Adjust until eyelids are 1 mm lower than normal. - Suture the skin, creating eyelids with nylon 7.0 - Fixed two stitches which pull down the cheeks with tape. - Apply antibiotic ointment, and compress-patch the eye. * Care and Post-operative follow-up - Medicine: Pain relief, antibiotic, anti-edematous, antibiotic ointment... - Apply cold compress for 48 hours, change the dressing daily, cut the stitches after 7 days, maintain 2 fixed stitches pulling down the cheek for 1 week with adhesive tape. * Follow-up - Visit again after 1 week, 1 month, 3 months, 6 months and 12 months. 10 * Detect complications and handle complications if any - Bleeding: mild: Use bandage, hemostatic drug, severe: Open the incision to remove the hematoma - Infected: antibiotics combined with immunotherapy - Injury of the eyeball: Treatment depends on each injury - Granulomas: Removing granulomas under surgery. - Occur again periodically: Re-surgery after 6 months if indicated. 2.2.6 Research variables and indicators The research results were collected through research records and evaluated and categorized according to Mourits and Sasim's research. Results are evaluated at 1 month, 3 months, 6 months and 12 months before and after surgery. Research variables and indicators are categorized as follows: Table 2.1: Methods to evaluate variables and research indicators Variable name Variable type Methods and tools for data collection Goal 1 MRD1 Quantitative Millimeter Ruler Research medical records PFH Quantitative C Quantitative SC Quantitative SC Quantitative Satisfaction Qualitative Goal 2 Age Quantitative Medical Inquiry Research medical records Subclinical examination Medical examination Sterile Compass Gender Qualitative Illness duration Quantitative Duration of disease stability Quantitative History of eye treatment Qualitative History of systemic disease Qualitative Cause Qualitative Position of UER Qualitative Damage to the ocular surface Qualitative Lagophthalmos condition Quantitative Scleral show Quantitative Lid lag Quantitative LF Quantitative Proptosis difference Quantitative Size of orbital septum flap Quantitative 11 2.2.7 Methods to evaluate overall results In the surgical evaluation criteria, the upper eyelid position index (MRD1), the C index, the PFH difference, the crease height, the crease height difference and the patient satisfaction level are the criteria that affect the overall outcome of surgery, In which MRD1 and eyelid contour C are the other main criteria, the remainders are sub-criteria [95]. The criteria related to the general outcome of surgery are categorized and evaluated according to the following score level: Table 2.2: Evaluate research criteria Critera 3 points 2 points 1 points MRD1 2,5–4,5 mm > 4,5–5,5 mm or 1,5– 2,0 mm >5,5 mm or <1,5mm  PFH 2 mm Curvature (C) < 1 mm < 2 mm  2 mm Skin crease 5 – 7 mm 7 – 10 mm 10mm  Skin crease 2 mm Table 2.3: Assess the level of patient satisfaction Criteria 3 points 2 points 1 points Satisfaction level Very satisfied Satisfied Not satisfied Evaluate general results according to the above criteria with 3 levels: Good, medium and poor based on the results of the overall scores of each research indicator according to Mourit and Sasim's classification as follows: Table 2.4: Evaluate the results according to the levels Class: Good Average Poor Total score 15 12-14 < 12 and at least 1 main indicator is poor Evaluation after surgery, results are good and average is considered successful, poor results are considered failure. 2.3 Data processing and analysis Data collected from research records will be processed using medical statistical methods using SPSS 16.0 software. 12 CHAPTER 3 RESEARCH RESULTS Our study was conducted on 43 patients with 46 moderate-to-severe UER eyes who were examined and treated with extending levator muscle surgery Orbital septum flap at Vietnam National Eye Hospital since October 2016 to October 2019. Through data analysis we have obtained the following results: 3.1 Characteristics off the researched subjects 3.1.1 Patient characteristics In the study, 43 patients including 41.80%. The average age is 33.35  32.5 years old. Age group 17 - 50 has the highest proportion, accounting for 86.04%. 3.1.2 Eye characteristics 7/46 eyes studied were caused by thyroid related to orbitopathy (15.22%), 7 congenital UER eyes (15.22%), 69.56% temporarily idiopathic. 11 patients with a history of pathology (diabetes, hypertension...) accounted for 25.58%. 74.42% of study patients had no previous medical history. 13.04% of eyes had a history of previous eye surgery. Visual acuity of the group under 20/70 accounts for the highest proportion with 86.96%. The subjective symptoms for patients who visit and receive treatment include 3 blurred vision (6.50%), 2 red eyes (4.30%), 4 teary eyes (8.70%) and 5 limited mobility (10.90%). 69.57% of patients come for aesthetics treatment. 28.30%, eyes had slight damage to the surface of the eyeball (superficial keratitis, fibrous keratitis, dry eye). The average duration of illness was 68 months. The median duration of stable treatment was 61 months. The study was conducted on 10 severe UER eye (21.74%) and 36 medium UER eye (78.26%). 36 eyes had UER in the central position (center 1/3). The average MRD1 and PFH of the two groups was 5.97 ± 0.85 mm and 12,65  1,41 mm, respectively. The group of severe UER had the largest sclera show of 2.30 ± 0.95 mm, which is higher than the level of moderate UER, of 1.53 ± 0.56 mm. The sclera show degree of 1.70 ± 0.73 mm. The eyelid curvature of the severe group was 1.20 ± 2.53 mm. The average lid lag of the 2 groups was 2.26 ± 1.07. The levator function and skin crease are and 5.38 ± 0.89 mm 14,24  2,12 mm, respectively. 13 The average proptosis for the severe UER group was 15.00 ± 1.33 mm. The average lagophthalmos degree of the study group was 0.15 ± 0.42 mm. 3.2 Surgical results 3.2.1 During surgery The average surgery time is 37.5 ± 5.48 minutes The shortest surgery time is 28 minutes, the longest is 45 minutes. The average height of the orbital septum flap used in surgery is 5.28 ± 0.77 mm. The height of the orbital septum and MRD1 are linearly related by the equation: The height of the flap = 0.02 x MRD1 + 5.24 (p > 0.05). The average follow-up time after surgery is 22.06 ± 12.03 months. The longest follow-up patients were up to 37 months; the shortest follow-up patients were 12 months (p > 0.05). 3.2.2 After surgery Visual acuity of the group under 20/70 accounts for the highest proportion with 86.96%. There was no difference in visual acuity of patients before and after treatment (p = 0.026). After surgery, all subjective symptoms have improved with p < 0.05. 1 month, 3 months, 6 months and 12 months after surgery, 95.7% of the eyes had no damage to the ocular surface, p = 0.001. For UER in the center 1/3, after 6 months and 12 months, there was 2.17% of the UER recurrence at this location. For the UER lateral 1/3 there were 6.52% of eyes with UER 1/3 lateral recurrent at 6 and 12 months (p < 0.05). 3.2.2.1 Physical features and functions of eyelid and eyeball * MRD1: MRD1 of UER eye decreased from 5.96 mm to 3.42 mm 12 months after surgery. The MRD1 difference between the two eyes decreases from 2.62 mm to 0.03 mm after surgery (p > 0.05). * PFH: Before surgery, the average PFH was 12.65 mm. After surgery the PFH index of the UER eye returned to approximately the same as the normal eye index (9.90 mm) p > 0.05. * SC: The skin crease in UER eyes before surgery is 5.38 mm, lower than in the normal eyes is 6.21 mm. The skin crease increased 1-month postoperative time and then gradually decreased to the level equivalent to the skin crease of normal eye after 12 months, p> 0.05. * Sclera show degree: Before surgery the largest indext is in the group of severe eyelid retraction with 2.30 ± 0.95 mm while this value in the group of general eyelid retraction is 1.70 ± 0.72 mm,p <0.05. At the time of post-operative studies, the difference in sclera show was reduced to an almost normal level of 0.01 mm. 14 * C: Before surgery, the curvature and the difference in eyelid curvature of both eyes were 1.09 ± 2.14 mm. After surgery, these two indicators decreased to 0.35 ± 1.21 mm, p > 0.05. * Lid lag: Before surgery, the lid lag was 2.26 ± 1.07 mm and decreased after surgery as -0.73 ± 0.66 mm (p = 0.001). * LF: LF before the surgery was 14.24 ± 2.12 mm and after surgery 12 months is 14.41 ± 2.05 mm, p= 0,042. * Lagophthalmos degree: The gap of the eyelid before surgery is 0.15 ± 0.42 mm. After surgery, no lagophthalmos, p< 0.05. * Ocular surface exposure and difference proptosis: The proptosis before surgery 14.35 ± 1.49 mm and after surgery 14.07 ± 1.40 mm. The difference in proptosis between the eyes before and after surgery is 0.80 ± 0.92 mm with p <0.05. No lagophthalmos post-operation. 3.2.2.2 Satisfaction level The rate of very satisfied with the surgical results at 1-month time was 69.56%, this rate increased gradually during the follow-up and at 12 months the rate of very satisfied with results was 84.78%. 3.2.2.3 Complications There were 3 cases of conjunctival tear less than 3 mm, so there was no need to sew. 5 cases had bleeding during surgery. However, hemostasis was cured immediately during the operation. Post operation, there were 4.53% edema, 2.17% hemorrhage subconjunctival, 2.17% recurrent in the center 1/3 and 6.51% of lateral 1/3. 3.2.2.4 Over-time surgical results and general outcomes * One month after surgery At the time of 1 month after surgery, the surgery success rate was 89.13%, in which the successful surgery rate of UER in severe cases was 90.00% and medium UER group was 88.39% with p > 0.05. * Three months after surgery At the time of 3 months after surgery, there were 44 eyes with successful surgery accounted for 95.65%. The group of severe EUR having the rate of good surgical results was 80,00%, higher than the moderate group which was 75% with p > 0.05. * Six months after surgery The surgery results at the time of 6 months showed that the success rate was 91.30%. The rate of good results of moderate and severe group had little difference with values of 70.00% and 66.67% with p > 0.05, respectively. 15 * Twelve months after surgery and general results After 12 months, 91.30% of eyes achieved successful results with 78.26% good results and 13.04% average level, 8.70% failed after surgery. The moderate and severe group had the same good rate. 3.3 Factors related to surgical results 3.3.1 Position of eyelid retraction and surgical results Successful surgical results and position of UER were statistically significant (p <0.05). 3.3.2 History of ophthalmic treatment and surgical outcomes There was a difference in the rate of achieving good surgical results after 12 months and a history of eye treatment, but this difference was not statistically significant (p <0.05). 3.3.3 Relationship between age and surgical outcome The difference is not statistically significant in the successful surgical results and age group. In the age > 50, the rate is 100% and in the group of 16 - 50 is 90,00% and the age 0.05. 3.3.4 Gender and surgical outcome The male rate of successful results after 12 months is 85,70% and the rate of women is 96.00%, there is not statistically significant a difference in the successful rate in gender groups, p > 0.05. 3.3.5 Etiology and surgical outcome The thyroid-related cause group had a successful rate of 71,40%. The successful rate of group with idiopathic is 93,80%. However, the correlation is not statistically significant with p> 0.05. 3.3.6 Systemic medical history and surgical results The group without a history of systemic illness had a success rate of 93.75%. The group with a history of systemic illness had a success rate of 81,82%, but the correlation was not statistically significant (p> 0.05). 3.3.7 Duration of diseases and surgical outcome There is a difference in the rate of successful surgical results, but the difference is not statistically significant (p> 0.05). 3.3.8 Degree of eyelid retraction and surgical outcome The successful rate is equivalent to the the severe group which is 90.00% and the moderate group which is 91.67% (p> 0.05). 3.3.9 Ocular surface damage and surgical outcome There is a difference in the rate of successful surgery after 12 months and damage to the ocular surface damage. The difference was not statistically insignificant (p > 0.05). 16 3.3.10 Sclera show and surgical results There are differences in the rates of successful surgical outcomes after 12 months and the degree of sclera show. However, this difference is not statistically significant (p > 0.05). 3.3.11 Lid lag index and surgical results There is a difference in the successful rate of surgical results after 12 months and lid lag. However, this difference is not statistically significant (p> 0.05). 3.3.12 Relationship between LF index and surgical results The successful rate of surgical outcomes and an LF has a loosely- restricted linear relationship (p > 0.05). 3.3.13 Lagophthalmos condition and surgical results There was a difference in the rate of successful surgical results of the group with lagophthalmos and the healthy group. However, this difference is not statistically significant (p> 0.05). 3.3.14 Difference of the proptosis and the surgical outcome We have not found the closely relationship between the difference in the proptosis and the surgery result (p> 0,0,5). 3.3.15 Orbital septum flap size and surgical results There was a relationship between size of flap and surgical results after 12 months, but not statistically significant (p > 0.05). CHAPTER 4 DISCUSSION 4.1 Characteristics of researched subjects before surgery 4.1.1 Patient characteristics Age average is 33,35  32,25, from 17 to 50 accounts for the highest rate up to 86.04%. This result can be explained by that the age group of 17 - 50, is the working age and these patients have higher social need, so the aesthetic demand is also higher than other ages. Women to men ratio % in the research is 1.4:1, that is suitable for author Watanabe A's (female: male = 1.5:1). It is possible to explain the above results because this study performed a group of patients with upper eyelid retraction due to many different causes so there is no difference between men and women. Patients with a history of hypertension that need to be noted before taking medication for blood pressure before and during surgery. Patients with a history of diabetes are not only should pay attention to the issue of using medication during the preparation of surgery but also be monitored the incision status and general condition after surgery. 17 4.1.2. Characteristics of the researched eye 4.1.2.1 Cause This study found 7 eyes with Basedow stable for at least 6 months. During time of researching, we have found over 1/3 patients have UER with TRO but have uncondition for operation or requiring depression surgery to protect vision function. 4.1.2.2 Duration of disease and duration of stable disease The average duration of disease was 68 months. The average duration of stable disease was 61 months. Shaefer and his colleagues performed surgery on patients with Basedow disease for at least 6 months. This is considered a stable period of time to allow surgery. 4.1.2.3 History of ophthalmic treatment The results showed that 13.04% of the eyes had a history of previous eye surgery (4 eyes have a history of trabeculectomy on a patient diagnosed with TRO. Some hypotheses that hypertrophic scars cause pseudo-upper eyelid retraction because a hypertrophic scar prevents the eyelids from returning to normal. 4.1.2.4 Visual acuity Visual acuity with corrective lenses before treatment is mainly at 20/20 - 20/70. Vision of patients studied did not change after treatment. Thereby it can be found that for the study group of patients with relatively good corrected vision, upper eyelid retraction can cause vision changes but not much. Surgery to treat eyelid retraction does not affect the patient's vision after surgery. 4.1.2.5 Functional symptoms before and after surgery The rate of patients coming for surgery due to functional and physical symptoms is very small (3 eyes blurred, 2 eyes red eyes, 4 eyes watery eyes and 5 eyes have limited eye mobility). After surgery most of the functional symptoms are improved because surgery reduces the ocular surface and corrects symptoms of lagophthalmos. 4.1.2.6 Physical signs before and after surgery * Condition of the ocular surface In the study, 13 eyes had slight damage to the surface of the eyeball (dry eyes, superficial keratitis, etc.). Most of the symptoms of damage to the surface of the eyeball have recovered after surgery, suggesting this is an effective method for treating UER. * Level of UER 18 The study showed that in the researched eye group, 21.74% of eyes had severe UER and 78.26% of eyes had moderate UER. This result is similar to the study results of the author Đ.V.Nghĩa (2013). After surgery, there were 3 mild recurrent UER associated with recurrent thyroid condition. It can be seen that the method of using the orbital septum flap is effective for moderate to mild UER. * Position of UER In the study, center 1/3 eyelid retraction eyes accounting for 78.26% and lateral 1/3 UER accounted for 21.74%. This result is lower than that of the author Đ.V.Nghĩa. Thereby, it can be seen that adjusting the retraction of the eyelid in the lateral 1/3 is a difficulty for the surgeon, and is also a factor that needs to be explained and prognosed for patients before surgery. 4.1.2.7. The condition of the eyelids and eyeball before and after surgery Factors assessed on eyelid morphology and function of eyelid retraction include: * MRD1: The average MRD1 before surgery was 5.97 ± 0.85 mm. After surgery, the MRD1 index decreases to 3.42 ± 0.26 mm and a two- eye difference after 12 months of 0.03 ± 0.22 mm (p> 0.05). It can be seen that after 12 months of follow-up, the difference in MRD1 between the two eyes returned to nearly normal values, proving the effectiveness of surgery in improving the eyelid function and aesthetics. * PFH: The average height of the eyelid gap before surgery was 12.65 ± 1.41 mm, in which in the severe UER group was 13.20 ± 1.36 mm, larger than the moderate UER group of 12, 50 ± 1.40 mm. After 12 months of surgery, the height of the eyelid gap was reduced to 10,10 ± 0,29 mm. Thus, this method effectively helps to improve eyelid gap height at different levels. * SC: The average skin crease before surgery were 5.38 ± 0.89 mm. The difference in the skin crease between the two eyes at 12 months after surgery was 0.01 ± 0.22 mm. Thereby, besides the improvement of the function of the eyelids an