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1 INTRODUCTION TO THESIS INTRODUCTION In patients with inadequate or absence of capsular support, the implantation of IOL using scleral-fixated technique with the haptic placed in sulcus, similarly to the natural anatomy of the lens, helps restore the physiological structure of the eyeball, thus resulting in good anatomical and functional outcomes The use of intraocular endoscopy helps easily approach peripheral structures of the posterior segment (ciliary sulcus,…) especially in difficult conditions such as small, irregularly shaped pupil This allows the surgeon to observe and perform more accurately, improve the quality of the surgery and provide better outcomes to patient Therefore, we conducted this study "Study the outcomes of scleral fixation of intraocular lens using intraocular endoscopy" to improve the accuracy of surgery, avoid complications, thus improving the outcomes of treatment, optimizing vision for patients with the following objectives: Describe clinical features of eyes without lens and posterior capsule Evaluate the outcomes of scleral-fixated intraocular lens implantation using intraocular endoscopy Analysis of factors related to the outcomes of surgery NOVEL FINDINGS: - This is the first study to evaluate the overall results of scleral-fixated intraocular lens implantation using intraocular endoscopy in Vietnam - Additional research, provide better understanding of clinical features and causes of aphakia and damage of posterior capsule - Study the application of new tool in ophthalmology: intraocular endoscopy in scleral-fixated IOL implantation to help increase success rate, reduce complications - The scleral fixated technique of cover the suture inside the sclera helps reduce the incidence of postoperative complication: suture erosion, with the use of the suture 10/0 poly propylene which is very common and can be used at lower level hospitals OUTLINE: The dissertation consists of 131 pages, including chapters Introduction (2 pages); Chapter 2: Objectives and Methods (17 pages), Chapter 3: Results (39 pages), Chapter 4: Discussion (32 pages), Conclusions and Recommended (3 pages) - There are also references, annexes, tables, charts, pictures illustrating the results of the treatment 2 CHAPTER LITERATURE REVIEW The use of intraocular endoscopy in ophthalmology Intraocular endoscopy is used in ophthalmology for reasons: first, this device allows surgeon to observe the posterior segment even when there’s an opaque in the visual axis which obscures the view as corneal scar, hyphema, small pupil, cataract or subcapsular cataract Second, intraocular endoscopy can help visualize intraocular structures that other devices fail to produce, such as behind the iris, sulcus, ciliary body, the pars plana and the peripheral retina Indication of using intraocular endoscopy: - Diseases which required intervention but in associated with other diseases that obstruct the observation with a non-contact microscope: + Corneal edema, corneal opaque + Damages of cornea, ICE, hyphema + Eyes with previous surgery such as iris fixation IOL + Cataract, sub-capsular cataract induced by corticosteroid + Surgical abnormalities: gas in anterior chamber, subluxation IOL, subluxation lens - Ophthalmic diseases: + Retinal Detachment with retinal tear in peripheral + Trauma + Endophthalmitis + Scleral rupture with vitreous rent + Small cornea + Aphakia, subluxation IOL + Refractory glaucoma Scleral fixation of intraocular lens In 2003, the American Society of Ophthalmology reviewed the methods of placing intraocular lens in patients without capsular support and concludes that sclera fixation of intraocular lens is a safe and effective method * Choose the type of intraocular lens: - The total intraocular lens diameter must be from 12.5 to 13mm - Optical diameter of the intraocular lens must be 6mm or wider - Intraocular lens: The angle between the optical part and haptic part is about 10 degrees, type of intraocular lens which are commonly used: Alcon CZ70BD (Alcon, Fort Worth, Texas), Bausch and Lomb 6190B (Bausch and Lomb, San Dimas, California) * Calculate the power of the intraocular lens: Formula for intraocular lens power calculation The constants used for the SRK formula relate to many factors such as the location of the intraocular lens, the technique to be used, the choice of the intraocular lens type This formula (P = A-2.5L-0.9K) has a known A value for each type of intraocular lens so it is easy to use When intraocular lens is placed in the ciliary sulcus, the reduction of intraocular lens power to 0.5 D is recommended by the authors * Suture using in sclera fixation of intraocular lens: The only fixed material used is polypropylene material due to long time stability in the eyeball Depending on the technique selected each author uses the needle with different shape like straight needles, curved needles but still the same polypropylene material * Sclera fixation of intraocular lens: Before sclera fixation of intraocular lens, vitrectomy should be performed to prevent contraction, the vitreous should be cleaned around the region of ciliary sulcus where the needle will go through Sclera fixation of intraocular lens is carried out through the following main steps: + Position selection for suture fixation: the position chosen depends on the number of fixed positions needed, but often symmetric, and often avoid the meridian 3-9h due to the large ring of the cornea, easily lead to hemorrhage + Suture will be fixed at 0.75 to 1mm from the limbus + Tie the suture to the haptic of IOL, insert IOL into anterior chamber + Suture the haptic into the sclera * Suture knot burried methods used for sclera fixation of intraocular lens: + Leave the suture knot on the sclera surface + Cover the suture knot by artificial corneal flap + Cover the suture knot by the flap of Fascia lata or Dura mater + Cover by the scleral flap + Create the continuous suture knot, rotate the suture inside + Create the grooves near the limbus, put the suture knot at or 4 position + Burried the suture knot in the sclera tunnel + Cover the suture knot by Z shape * Needle passing technique: + Technique to place the needle passed from the internal to the external of the eyeballs: This technique less distorts the eyeballs, but because the passing area is obscured, therefore, the needle can to pierce into the ciliary body, ciliary processes causing intraocular hemorrhage + External needle-passing needle technique was first described by Lewis (1991) The advantage of this method is to accurately locate the position for the needle to pass, so the ability to place accurately into the ciliary sulcus is very high * Techniques to tie the suture into the haptic of intraocular lens +Technique for tying a noose: is usually applied in cases where the intraocular lens without holes on the haptic, the surgeon usually use suegical instrument to clamp the haptic of intraocular lens to be flattened head, the noose will not slip + Technique of putting the loop suture through the holes on the haptic of the intraocular lens: The piercing method is only fixed through the holes on the haptic of intraocular lens to force the knot to be made only according to the twisting technique and to create a continuous noose loop Picture 1.1 Technique of putting the loop suture through the holes on the haptic of IOL * Scleral-fixated of intraocular lens using intraocular endoscopy Using intraocular endoscopy allows the surgeon to observe the unobserved areas behind the iris of the eyeball, especially the ciliary sulcus The endoscope allows the surgeon to know exactly the right position of intraocular lens and at the same time to control the complications that can occur during surgery such as bleeding, Picture 1.2 Suture goes through 30G needle and endoscopy inserted into the eyeball Picture 1.3 Steps of cover the knot into the scleral * Complications of posterior chamber IOLs in aphakic patients + Cystoid macular edema + Endophthalmitis + Vitreal hemorraghe + Subluxation IOL + retinal detachment + Choroidal hemorrhage + Suture erosion CHAPTER SUBJECT AND STUDY METHOD 2.1.Subjects: The study was conducted at the Trauma Department of Vietnam national institute of Ophthalmology from December 2010 to December 2015 2.1.1.Inclusion criteria: Patients over years of age with history of intracapsulcar cataract extraction, aphakia or damages to posterior capsular due to different causes, who undergone examination and treatment at the Trauma Department, have best visual acuity increasing with Snellen chart 2.1.2 Exclusion criteria: Patients with acute eye diseases such as conjunctivitis, dacryocystitis, abnormal coagulation, phthisis bulbi, abnormal macular, optic disc atrophy, retinal detachment, heart disease, system diseases, diabetes 6 2.2 Research methods 2.2.1 Study design: This is a prospective study, clinical trial, vertical follow up, no control group Patients were monitored from hospital admission, hospital discharge and month, months, months, year after discharged The data were collected according to the individual case study form 2.2.2 Sample size: The sample size is determined by the formula From the formula we can calculate the sample size in the study: n = 92 eyes We selected 103 eyes of patients with eligible criteria for inclusion in the study, a follow-up period of at least 12 months 2.2.3 Protocol 2.2.3.1 Preoperative clinical manifestations: a) History taking + Age, gender, occupation, address and telephone number of the patient History of the disease: chief complain Systemic diseases Previous surgery, when, where? How long does it take, what happens after previous treatments? (refer to old medical records if available) Ophthalmic examination: * Functional exams: Vision acuity, best corrected vision acuity to prognosis postoperative visual acuity, using Snellen chart Measure IOP using Maclakop tonometer * Examination: cornea, iris, pupil, iris, tear, degeneration, iris coloboma, anterior chamber Ophthalmoscopy to evaluate the posterior segment Functional tests 2.2.3.2 Surgical techniques in this research : Insert a 23G trocar at pars plana, 3,5 mm from the limbus at the meridian of 8h30 in the right eye and at the meridian of 4h30 with the left eye to keep the eye pressure stable during surgery Open conjunctival at meridians 2h and 8h or 4h and 10h + Make a deep grooves of ½ thickness of sclera (using 15 degree knife), usually perpendicular and mm to the limbus, two symmetrically 180 degrees at the opening of the conjunctiva Cut the superior of the cornea with 3mm length into the anterior chamber, cut the remaining vitreous (if any), inject viscoat into anterior chamber to protect corneal endothelium 7 + Put 10/0 polypropylene through 30G needle, suture 10/0 polypropylene is cut in the middle, threaded each end without the needle of the thread cut into the 30G needle from the tip of the needle towards the head needle (drawing) Picture 2.1 Put the polypropylene suture through the 30G needle Using the endoscope to see the ciliary sulcus, the endoscope goes into the eyeball through the corneal incision on the edge of the upper The surgeon moves the endoscope into the ciliary processes area corresponding to the scleral groove, while the other hand inserted 10/0 suture from the outside into the eyeball through the incision 1mm from limbus Observe under the intraocular endoscopy, the needle is inserted into the eyeball, the surgeon can adjust the needle to insert accurately to the right position Withdraw endoscopy from the eyeball, use hook to pull the suture outward through the upper corneal incision, the surgeon repeats the procedure to the opposite side + Tie the suture to IOL using continuous knot (Figure) Pull the straps through the hole of IOL CZ70BD, draw up and round through the tip of the IOL, then pull the suture to fixed IOL, the straps will be tied strongly into the IOL Picture 2.2 Suture loop fixed on the haptic + Corneal incision, insert IOL into posterior chamber Fixated IOL into the scleral using continuous loop, cover the knot into the scleral + Close conjunctive Close corneal incision by or poly propylene 10/0 suture + Note all details into surgical notes 2.2.4 Study Variables and Indicators * Preoperative clinical manifestations: Age distribution, sex, occupation, causes and time since the damages of posterior capsule, type, number of previous surgeries, Visual acuity without glasses and the best corrected vision acuity before surgery Characteristics of IOP, refraction of patients before surgery Eye injuries before surgery: cornea, iris, vitreo, retina *Study indicators relating to Outcomes +Post – operative best corrected visual acuity (BCVA): The best assessment of vision changes after surgery: Vision changes are evaluated by increasing, decreasing, or unchange visual acuity compared to before surgery Visual Acuity increased • VA ≥ 20/200: increase at least one row in the Snellen chart • VA from FC 1m to 20/200: vision increased from 20/400 or above • VA 0.05) 3.2.5 General surgical outcomes After 12 months, of the 103 eyes being operated, eyes were considered to be failures despite increased vision after surgery, however, the suture did not appeared on the conjunctiva so no further treatment is needed The success rate in our study was 94.18% Difference with success and failure group was statistically significant with p 0.05) BCVA in group undergone vitrectomay ans lensectomy with or without cornea scleral suture is significantly higher than the group who was underone surgery for retinal detachment, endophthalmitis, foreign body and lens removal VA difference in both groups was statistically significant at all postoperative follow-up (p