散瞳劑與角膜塑型術(OK鏡片)的使用與兒童雙眼視覺相關研究

 Accommodation and vergence function in children using atropine combined with orthokeratology - PubMed (nih.gov)

62位8-12歲兒童分為四組，第一組結合使用0.01% atropine與OK鏡片，第二組使用安慰劑與OK鏡片，第三組使用0.01% atropine與鏡框眼鏡，第四組控制組使用安慰劑與鏡框眼鏡。

研究開始與三個月後，評估雙眼視覺功能，包括horizontal phoria, fusional vergence, the accommodative convergence/accommodation (AC/A) ratio, accommodative lag, and accommodative amplitude (AA)。

結果

1.調節遲緩僅OK鏡片組有顯著改進，其他三組未改變

Accommodative lag significantly decreased in the OK group (P = 0.002), but remained unchanged in the other three groups (all P > 0.05).

2.雙眼調節靈巧度與正相對調節在結合組與OK鏡片組有進步，其他兩組未改變

Binocular accommodative facilities and positive relative accommodations increased in the combination and OK groups (both P < 0.05) , but remained unchanged in the atropine and control groups (both P > 0.05). 

3.僅OK鏡片組的內斜位有顯著降低。

Only the participants with esophoria in the OK group had a significant decrease in esophoria (P = 0.008).

4.融像性聚散與AC/A在四組間無顯著差異

Changes in fusional vergence and AC/A did not significantly differ between the four groups (all P > 0.05).

光線強度、藍光與近視

http://wechat.fingerdaily.com/thread-107470-1-1.html

以上是google查到的圖-犯了那些錯誤呢?

沒時間的就直接看結論與建議! 有部分可能跟您所想的不同!

結論

1. 實驗顯示，在低光照時，眼睛會對於影像劣化較為敏感，長時間低亮度近距離工作，會導致近視容易增加。
2. 從統計數據來看，學童每天於戶外明亮環境活動能有效對抗近視發展。
3. 在成長階段，短波長的光(接近藍光的波長)似乎對眼球的生長有一定的調節作用，且較能抑制近視的發生。

建議

1. 每天要有一段時間於戶外明亮光線下活動。
2. 近距閱讀工作，要有明亮且舒適的白光照明。
3. 不要為了趕潮流長時間(包括室內)配戴太陽眼鏡。
4. 不建議成長中的學童配戴抗藍光鏡片，無益於近視控制。
5. 關於藍光的傷害-不管何種波長，只要能量過強，都會傷害視網膜。

有興趣的就看看以下相關的研究結論及參考文獻~

一、關於光亮度與近視的研究文獻

1. 學校兒童夏季的近視增加較慢。
2. 雞近視實驗--高亮度環境飼養雞未近視，低亮度環境卻製造近視；高亮度環境飼養雞其中一眼戴太陽眼鏡，帶鏡眼近視。高亮度的環境，不管陽光或人工燈光，皆能阻止雞近視形成
3. 光亮度阻止近視可能與dopamine(一種神經傳導物質，經研究與近視的形成有關)有相關性，實驗雞注射dopamine拮抗劑能消除光的保護作用。
4. 猴實驗類似，且發現連續5小時以上高光照才有效。
5. 也能解釋戶外活動對近視防治的效果。
6. 對眼的影像品質--亮光-瞳孔縮小能增加焦深，使網膜上影像清晰。暗-瞳孔放大-球面像差增加(近視者像差較正視者大)。
7. 低亮度對雙眼視覺也有負向作用，若有內斜問題者情況會惡化。

二、關於光波長與近視，目前的實驗及研究

色光--  紅橙黃綠藍紫

波長--   較長--- 較短

1. 光具有色散現象-過濾藍光鏡片會表現出輕微近視。
2. 此色散現象是否會影響人眼偵測網膜影像焦點的正確性及正視化的進行仍有爭議。
3. 近讀時選擇性地消除長波長，明顯降低調節刺激約0.50D，顯示視覺系統近讀時主要使用長波長光，在分子生物研究中也得到類似的結論。
4. 豬近視實驗--長波長燈光環境下飼養的豬較易近視及有較深玻璃體腔深度(眼軸長)。
5. 戶外活動較能減少近視增加，可能由於戶外光線波長較室內燈光短。
6. 帶著藍色鏡片於戶外活動，眼球生長較慢。
7. 藍光可能有益於人體中央神經系統的dopamine調整。
8. 鼠近視實驗--相對於正常白光，養於中波長環境的豬，發展出近視；而飼養於短波長環境的豬，發展出遠視。
9. 鼠近視實驗--即使用負鏡片誘發近視的豬，藍光都能抑制眼軸生長。
10. 雞近視實驗--紅光誘發近視，藍光誘發遠視。
11. 猴近視實驗--長波長光是近視的危險因子。

本文主要翻譯於Dr. rer. nat. Klaus Schmid, Physicist所著之

Myopia Manual Edition January 2015，P133-142。個人有所增刪。作者此部分章節所引用的參考文獻如下。

Cui D, Trier K, Munk Ribel-Madsen S. Effect of day length on eye growth, myopia progression, and change of corneal power in myopic children. Ophthalmology. 2013 May;120(5):1074-9    

Woung LC, Lue YF, Shih YF, Accommodation and pupillary response in early-onset myopia among 

schoolchildren, Optom Vis Sci 1998 Aug; 75(8): 611-6    

Charman WN, Radhakrishnan H. Accommodation, pupil diameter and myopia. Ophthalmic Physiol Opt. 2009 Jan;29(1):72-9    

Young, Francis A, The effect of nearwork illumination level on monkey refraction, Am J Optom and Arch Am Acad Optom 1969; 46(9), referenced in referenced in The prevention of acquired myopia, 

http://members.aol.com/myopiaprev/page2.htm    

Lang G, Augenheilkunde, Georg Thieme Verlag Stuttgart New York, 2000, p. 228 

Schaeffel F, Presseerklärung im Rahmen der 96. Tagung der Deutschen Ophthalmologischen Gesellschaft, 19. – 22. September 1998, Berlin    

 Feldkaemper M, Schaeffel F. Are retinal image brightness and spatial frequency distribution independently processed during deprivation myopia development? Investigative Ophthalmology and Visual Science 37: 1497(1996)    

 Ashby R, Ohlendorf A, Schaeffel F. The Effect of Ambient Illuminance on the Development of Deprivation Myopia in Chicks. Invest Ophthalmol Vis Sci. 2009 Jun 10.   

 Ashby RS, Schaeffel F. The effect of bright light on lens compensation in chicks. Invest Ophthalmol Vis Sci. 2010 Oct;51(10):5247-53. Epub 2010 May 5.    

 Optom Vis Sci. 2011 Vol. 88, No. 3; 13th International Myopia Conference Symposium Summaries, Symposium 5, Paper 2 by Ashby R and Morgan I    

 Moore, S. E., Irving, E. L., Sivak, J. G., Callender, M. G.: Decreased light levels affect the emmetropization process in chickens. In: Vision Science and its Applications. OSA Technical Digest Series, Vol. l (Optical Society of America, Washington DC), S. 202-205 (1998)    

 Schmid KL et al. The effect of common reductions in letter size and contrast on accommodation responses in young adult myopes and emmetropes. Optom Vis Sci. 2005 Jul;82(7):602-11    

 Cohen Y et al. Dependency between light intensity and refractive development under light-dark cycles. Exp Eye Res. 2010 Nov 3    

 Smith EL 3rd et al. Protective effects of high ambient lighting on the development of form-deprivation myopia in rhesus monkeys. Invest Ophthalmol Vis Sci. 2011 Dec 14  

Backhouse S, Collins AV, Phillips JR. Influence of periodic vs continuous daily bright light exposure on development of experimental myopia in the chick. Ophthalmic Physiol Opt. 2013 Sep;33(5):563-72   

Lan W, Feldkaemper M, Schaeffel F. Intermittent episodes of bright light suppress myopia in the chicken more than continuous bright light. PLoS One. 2014 Oct 31;9(10):e110906.   

 Roberts JE, Visible light induced changes in the immune response through an eye-brain mechanism 

(photoneuroimmunology), I Photochem Photobiol B 1995 Jul; 29(1): 3-15    

Norton TT1, Siegwart JT Jr. Light levels, refractive development, and myopia--a speculative review. Exp Eye Res. 2013 Sep;114:48-57.  

 Atchison DA, Smith G, Efron N, The effect of pupil size on visual acuity in uncorrected and corrected myopia, Am J Optom Physiol Opt 1979 May; 56(5): 315-23    

 Paquin MP, Hamam H, Simonet P, Objective measurement of optical aberaations in myopic eyes. Optom Vis Sci 2002 May;79(5):285-91    

 Owens, Liebowitz, Accommodation, convergence, and distance perceprtion in low illumination. Am J Optom Physiol Opt 1980 Sep;57(9):540-50   7    REFERENCES 341

 Kersten D, Legge GE, Convergence accommodation. J Opt Soc Am 1983 Mar;73(3):332-8    

 Vannas AE, et al. Myopia and natural lighting extremas: risk factors in Finnish army conscripts. Acta Ophthalmol Scand. 2003 Dec;81(6):588-95    

Lan W1, Feldkaemper M, Schaeffel F. Bright light induces choroidal thickening in chickens. Optom Vis Sci. 2013 Nov;90(11):1199-206.   

 Illuminance – Recommended Light Levels http://www.engineeringtoolbox.com/light-level-rooms-d_708.html    

 Millodot M, Stevenson RW, Electrophysiological evidence of adaptation to colored filters. Am J Optom Physiol Opt 1982 Jun;59(6):507-10    

 Schmid KL, Wildsoet CF. Contrast and spatial-frequency requirements for emmetropization in chicks. Vision res 1997 Aug;37(15):2011-21   

 Kroger RH, Binder S. Use of paper selectively absorbing long wavelengths to reduce the impact of educational near work on human refractive development. Br J Ophthalmol 2000 Aug;84(8):890-3    

 Kubena T, Kubena K, Galatik A, Neumann P. Effect of infrared rays on the eye in progressive myopia. Cesk Slov Oftalmol 1999 May;55(3):155-9    

 Long Q et al. Illumination with monochromatic long-wavelength light promotes myopic shift and ocular elongation in newborn pigmented guinea pigs. Cutan Ocul Toxicol. 2009;28(4):176-80.    

 Optom Vis Sci. 2011 Vol. 88, No. 3; 13th International Myopia Conference Symposium Summaries, Kexnote Lecture 3 by Neitz J and Neitz N.    

 Long Q et al. llumination with monochromatic long-wavelength light promotes myopic shift and ocular elongation in newborn pigmented guinea pigs. Cutan Ocul Toxicol. 2009;28(4):176-80.    

 Hathaway WE. Effects of School Lighting on Physical Development and School Performance The Journal of Educational Research Volume 88, Issue 4, 1995    

 Cowan RL et al. Differential effects of D-amphetamine on red and blue light-induced photic activation: A novel BOLD fMRI assay of human dopamine function. Synapse. 2008 Apr;62(4):268-72. doi: 10.1002/syn.20491.    

 Quian YF et al. Transfer from blue light or green light to white light partially reverses changes in ocular refraction and anatomy of developing guinea pigs. J Vis. 2013 Sep 26;13(11)    

Jiang L et al. Interactions of chromatic and lens-induced defocus during visual control of eye growth in guinea pigs (Cavia porcellus). Vision Res. 2014 Jan;94:24-32   

Foulds WS, Barathi VA, Luu CD. Progressive myopia or hyperopia can be induced in chicks and reversed by 

manipulation of the chromaticity of ambient light. Invest Ophthalmol Vis Sci. 2013 Dec 9;54(13):8004-12   

 Shang YM et al. White Light-Emitting Diodes (LEDs) at Domestic Lighting Levels and Retinal Injury in a Rat Model. Environ Health Perspect. 2014 Mar;122(3):269-76    

 Igor Kanin, Personal communication   a570 

 Liberman J, Light: Medicine of the future, Bear & Co, 1992 

新型漸進多焦(兒控)鏡片用於近視控制的兩年實驗

視光界最權威的期刊IOVS 2014最新的文章

結果再次證實了兒控鏡片控制近視的效果只有約20%

近用時減少調節的使用對於控制近視效果真的有限，就算加上周邊屈光差也沒有改善。

還不如單獨使用周邊屈光差設計的控制近視鏡片

顯示控制近視還是要從視覺影像著手，眼球的機械性力量(調節、內聚等等)的調整，改善程度有限。


---------------------------------------------------------------------------------
一種新型的漸進多焦鏡片，兩年、多中心、隨機、對照控制的近視控制實驗。

此種新型漸進多焦鏡片採用新設計的周邊正非球面設計

可以同時減少調節與視網膜周邊的遠視性離焦

197位6~12歲兒童參與實驗，等值球面近視在-1.00D ~ -4.50D
隨機分為三組，單焦組，多焦加入度+1.00D，多焦加入度+1.50D

兩年後的結果
單焦組 增加 -1.39 ± 0.09 D

多焦加入度+1.50D比單焦組減少0.27 ± 0.11 D

也就是控制近視效果約20%，統計上達顯著程度。

多焦加入度+1.00D則不具顯著控制近視效果。


Invest. Ophthalmol. Vis. Sci., 2014

Myopia Control with Positively Aspherised Progressive Addition Lenses: A two-year, Multicenter, Randomized, Controlled Trial.

Hasebe, S; Jun, J; Varnas, SR

PURPOSE: To evaluate the effect of newly-designed positively aspherised progressive addition lenses (PA-PALs), which reduce both lag of accommodation and hyperopic defocus on the peripheral retina, on progression of early-onset myopia.
METHODS: PA-PALs have a near addition and a high positive distance zone aspherisation comparable to the addition power. One hundred and ninety-seven children were enrolled, 6 to 12 years of age, with spherical equivalent refraction from -1.00 to -4.50 D. The children were randomized to receive one of three lenses: single vision lenses (SVLs), PA-PALs with +1.0 D addition, or PA-PALs with +1.5 D addition. Follow-up visits occurred every 6 months for two years. The primary outcome is myopia progression evaluated by cycloplegic autorefraction.
RESULTS: One hundred and sixty-nine (86%) children completed the follow-up. Statistical analysis of adjusted progression rates showed a mean (±SE) progression of -1.39 ± 0.09 D in the control group wearing SVLs at the 24-month visit. Statistically significant (p = 0.017) retardation of SER (0.27 ± 0.11 D over 24 months or reduction ratio of 20%) by +1.5 D add PA-PALs relative to the SVLs was found, which was within the range of the percentage efficacy of myopia retardation by the conventional PALs in earlier trials over the same follow-up period. Nearly all retardation occurred in the first 12 months with no significant efficacy in the second year. PA-PALs with +1.0 D addition showed negligible efficacy.
CONCLUSION: The high positive aspherisation of the distance zone added to PALs apparently does not enhance their therapeutic efficacy in slowing myopia progression.
Copyright © 2014 by Association for Research in Vision and Ophthalmology.

PMID: 25270192
URL  - http://www.ncbi.nlm.nih.gov/pubmed/25270192?dopt=Citation

周邊屈光不正(遠視化)對近視發展的影響

最近有一些研究論點指出，周邊的屈光不正對於近視發展有一定的影響，並據此發展出一些相關的處置方式。
不過經過一些證實，似乎還是有問題，事情並沒有這麼簡單。

首先來看什麼是周邊的屈光不正
引自http://www.myopiaprevention.org/definitions.html


近視定義屈光相對眼軸過強。
上圖表示中央近視，周邊也是近視


遠視定義屈光相對眼軸過弱。
上圖表示中央遠視，周邊也是遠視

這就是此理論所持的論點，即使中央影像清晰(表示視力正常)，
但若周邊屈光有遠視化的情形
仍將造成眼睛往近視的方向發展(眼球生長去符合焦點位置，因此增長，變形為橢圓形)。



若以光學的方式，改變進入眼睛的周邊光線性質，將可以改善周邊遠視化的現象。
(事實上參考資料提出這就是OK鏡片能讓近視增加減緩的原因，改變角膜形狀使周邊屈光改變)

以下論文(2011九月，燒的)可以證實近視眼的週邊的確是呈現遠視性屈光不正(較為橢圓形)，
而正視眼的眼球則較呈圓形。
Cross-sectional Sample of Peripheral Refraction in Four Meridians in Myopes and Emmetropes.

覺得哪裡怪怪的嗎? 這邊有一個問題產生，就是雞生蛋跟蛋生雞的問題?
也就是近視眼的週邊屈光的確是呈遠視化，但周邊的遠視化是否就是造成近視的原因呢?

(這種情形很像眼壓與近視的關係，近視者的眼壓較高，但眼壓高是否是近視形成的其中一個原因呢?)

要證實其間的關係，最好的方法就是去觀察正常眼睛一段時間，看之後周邊的變化。

恰好也是今年的論文(2011十月，剛發表，燙的，新加坡做的)

Change in Peripheral Refraction over Time in Singapore Chinese Children.

(同一個團隊在今年2月發表的論文支持了近視與周邊遠視化的相關性。)

而這一次他們找了187個兒童，追蹤了約一年半的時間，結論卻是

無法從原本的週邊屈光不正狀態，去預測近視的發生或影響近視的進展。
(Baseline peripheral refraction did not predict the subsequent onset of myopia or influence the progression of myopia)

當然這是很新的議題，目前的證據或研究也還不夠多。

尚不能就此定論此種近視控制方式(改變週邊屈光狀態)是無效的。

而事實上目前各種近視控制方法(藥物、角膜塑形、多焦鏡片...)都有一定的成效。

我想我等就只能繼續觀察，等待視光方面的科學家進一步的研究成果吧。

年輕成人的建議近用加入度

• 本篇論文根據年輕成人於視近時，評估其調節反應、眼位、注視差異(FD)，以決定最佳之加入度。
• 結論是在50cm，40cm，30cm之工作距離處，加入度分別為 +0.92 D、+1.04 D及 +1.28 D。
• 近方3個稜鏡外斜之最佳加入度分別為+0.58 D 、+0.35 D and +0.20 D。
• 此外，初始之調節反應誤差、近方眼位與最佳加入度之間有高度相關性。
• 研究者建議加入度之設計應同時考量調節與聚合系統之間的平衡，約在+0.20D到+1.28D之間
• 且若依每個人之調節與聚合系統，採用漸進多焦之設計，對於減緩近視的增加預期會有效果。

http://www.ncbi.nlm.nih.gov/pubmed/18981925
Optom Vis Sci. 2008 Nov;85(11):1100-5.
Optimal dioptric value of near addition lenses intended to slow myopic progression.
Jiang BC, Bussa S, Tea YC, Seger K.

Source

College of Optometry, Nova Southeastern University, Ft Lauderdale, Florida 33328, USA. bjiang@nova.edu

Abstract
PURPOSE:

The purpose of this study was to determine the optimal power value of near addition lenses, which would create the least error in accommodative and vergence responses.
METHODS:

We evaluated accommodative response, phoria, and fixation disparity when the subject viewed through various addition lenses at three working distances for 30 young adults (11 emmetropic, 17 myopic, and 2 hyperopic). Accommodative response was determined with a Canon R-1 infrared optometer under binocular viewing conditions, phoria was determined by the alternating cover test with prism neutralization, and fixation disparity was measured with a Sheedy disparometer.
RESULTS:

We found that the optimal powers of near addition lenses for the young adult subjects associated with zero retinal defocus were +0.92 D, +1.04 D, and +1.28 D at three viewing distances, 50 cm, 40 cm, and 30 cm, respectively. The optimal powers associated with -3 prism diopters (Delta) near phoria were +0.58 D, +0.35 D, and +0.20 D at the three distances, 50 cm, 40 cm, and 30 cm, respectively. In addition, we found high correlations between the initial accommodative error and the optimal power of the near addition lenses and between the initial near phoria and the optimal power of the near addition lenses.
CONCLUSIONS:

The results suggest that when the effects of near addition lenses on the accommodative and vergence systems are both considered, the optimal dioptric power of the near addition lens is in a range between +0.20 D and +1.28 D for the three viewing distances. Using progressive lenses to delay the progression of myopia may have promising results if each subject's prescription is customized based on establishing a balance between the accommodative and vergence systems. Formulas derived from this study provide a basis for such considerations.

漸進多焦(兒童控制近視)與單光鏡片對於高度調節遲緩及近方內斜位兒童近視減緩的比較

http://www.iovs.org/content/early/2011/01/31/iovs.10-6631.abstract

熱騰騰，2011年一月發表的論文。

根據理論，漸進多焦鏡片(用於兒童時，稱兒童控制近視鏡片)，對於某些特定兒童，具有較好的近視控制效果，也就是調節遲緩與近方內斜位的兒童對兒控鏡片的反應會比較好。

以下這篇今年的論文提供了更多的證據。

對象選取為118位年齡在8~12歲，等值球面在-0.75D~-2.50D，且近方內斜位大於2個稜鏡度以上者，進行雙盲、多中心、隨機試驗。

調節遲緩的量一開始定義為至少0.50D，後來修改為至少1.00D。104個兒童調節遲緩高於1.00D，14個孩童調節遲緩在0.50D~0.99D。

兒童隨機分為接受加入度+2.00D的漸進多焦鏡片或標準單焦鏡片，且家長及兒童並不知道所配戴的鏡片種類。

6個月間隔的隨訪持續了三年。每年年度的檢查都採用散瞳後的電腦驗光數據作為比較。

結果三年後漸進多焦組的等值球面平均變化為-0.87D，單焦鏡片組為-1.15D，差距為0.28D。

結論是有統計上的差異，但臨床上的效果並不是非常明顯。

Progressive Addition Lenses versus Single Vision Lenses for Slowing Progression of Myopia in Children with High Accommodative Lag and Near Esophoria

1. Correction of Myopia Evaluation Trial 2 Study Group for the Pediatric Eye Disease Investigator Group

1. Correspondence and reprint requests to: Jane E. Gwiazda, PhD., c/o Jaeb Center for Health Research, 15310 Amberly Drive, Suite 350, Tampa, FL 33647; Phone:(813) 975-8690, Fax: (813) 975-8761, E-mail: pedig@jaeb.org

Abstract

Purpose: To determine if progressive addition lenses (PALs) relative to single vision lenses (SVLs) slow the progression of low myopia in children with high accommodative lag and near esophoria.

Methods: One hundred eighteen children aged 8 to <12 years with spherical equivalent refraction (SER) from -0.75 to -2.50D and near esophoria ≥ 2PD were enrolled in this double-masked, multi-center, randomized trial. A key additional eligibility criterion was high accommodative lag, initially defined as at least 0.50D (accommodative response less than 2.50D for a 3.00D demand) and later restricted further to at least 1.00D. One hundred four subjects had accommodative lags at least 1.00D and 14 had lags between 0.50 and 0.99D. Children were randomized to receive either PALs (Essilor Ellipse) with a +2.00D addition or standard SVLs. The clinicians performing the outcome testing, as well as the children and their families, were masked to treatment group. Follow-up visits occurred every 6 months for 3 years. At annual visits, refractive error was assessed in each eye using cycloplegic autorefraction. The main outcome measure was change from baseline to three years in SER by cycloplegic autorefraction.

Results: The mean change in SER between baseline and the 3-year primary outcome visit was -0.87D in the PAL group and -1.15D in the SVL group, for a difference of 0.28D (95% confidence interval = 0.01 to 0.55D).

Conclusion: The PALs used in this study were found to have a statistically but not clinically significant effect on slowing myopia progression in children with high accommodative lag and near esophoria.

近視控制新藥pirenzepine兩年的實驗成果

Pirenzepine(哌崙西平)
M₁選擇性拮抗劑，用於治療消化性潰瘍 ，因為它能減少胃酸分泌，降低肌肉痙攣 。
由於它的特性，能選擇性作用於睫狀肌麻痺，但卻較不會讓瞳孔放大。因此近年來有研究將它用於近視控制。


如下面這一篇，美國兩年的多中心、隨機、雙盲、安慰劑控制研究的2% Pirenzepine在兒童近視方面的安全性與有效性的論文。

實驗對象:
8~12歲，等值球面在-0.75D~-4.00D，散光不大於1.00D，以2:1的比例隨機分配到實驗組(2% Pirenzepine眼凝膠)與對照組，一天點用兩次。實驗結果測量為散瞳後之電腦驗光數據。

結果:
實驗開始時，實驗組 -2.10 +/- 0.90 D (mean +/- SD) (n = 117) ，對照組 -1.93 +/- 0.83 D  (n = 57; p = 0.22)。


一年後，實驗組近視平均增加 -0.26 D，對照組增加-0.53 D  (p < 0.001)


84個患者選擇繼續第二年的實驗，(pirenzepine = 53, placebo = 31)


第二年，實驗組近視平均增加 -0.58 D，對照組增加-0.99 D (p = 0.008)


13個實驗組患者(11%)在第一年時，由於藥物副作用退出實驗。第二年時有一位退出。


結論: 
Pirenzepine 眼凝膠 2% 相比於安慰劑在減緩近視增加方面是有效的，而在兩年治療期間臨床上的安全性是可接受的。

http://www.ncbi.nlm.nih.gov/pubmed/18359651

J AAPOS. 2008 Aug;12(4):332-9. Epub 2008 Mar 24.

Two-year multicenter, randomized, double-masked, placebo-controlled, parallel safety and efficacy study of 2% pirenzepine ophthalmic gel in children with myopia.

Siatkowski RM, Cotter SA, Crockett RS, Miller JM, Novack GD, Zadnik K; U.S. Pirenzepine Study Group.

Dean McGee Eye Institute/University of Oklahoma Department of Ophthalmology, Oklahoma City, Oklahoma. USA.

Comment in:

• J AAPOS. 2008 Aug;12(4):322-3.

Abstract

PURPOSE: To evaluate if the safety and efficacy of the relatively selective M1-antagonist, pirenzepine, in slowing the progression of myopia in children is sustained over a 2-year period.

METHODS: This was a multicenter, parallel-group, placebo-controlled, double-masked, randomized clinical trial. Enrolled were children aged 8 to 12 years, with entry spherical equivalent refractive error of -0.75 to -4.00 D and astigmatism

RESULTS: At study entry, spherical equivalent was -2.10 +/- 0.90 D (mean +/- SD) for the pirenzepine group (n = 117) and -1.93 +/- 0.83 D for the placebo group (n = 57; p = 0.22). At 1 year, there was a mean increase in myopia of 0.26 D in the pirenzepine group versus 0.53 D in the placebo group (p < 0.001). Eighty-four patients elected to continue for a second year (pirenzepine = 53, placebo = 31). At 2 years, the mean increase in myopia was 0.58 D for the pirenzepine group and 0.99 D for the placebo group (p = 0.008). Thirteen (11%) pirenzepine patients dropped out due to adverse effects in the first year, and 1 did so in the second year.

CONCLUSIONS: Pirenzepine ophthalmic gel 2% was effective compared with placebo in slowing the progression of myopia over a 2-year treatment period and demonstrated a clinically acceptable safety profile.

PMID: 18359651 [PubMed - indexed for MEDLINE]

近用稜鏡雙焦眼鏡能減緩近視增加-兩年的臨床測試

近用眼鏡加入稜鏡是一個可行的方向，在放鬆調節的同時，也放鬆了聚合。


為了測試雙焦與稜鏡雙焦眼鏡是否能控制兒童近視增加的速度，此臨床測試隨機選取135位每年近視增加-0.50D以上中國兒童，1並隨機分為三組(1)單焦鏡片(2)加入度+1.50D之雙焦鏡片與(3)加入度+1.50D並加入3個BI稜鏡之雙焦鏡片
。
測量以散瞳後電腦驗光之近視度數與超音波測量眼軸長為實驗數據，以6個月間隔測量24個月。


結果(1)單焦鏡片組平均近視增加-1.55D (2)雙焦鏡片組平均近視增加-0.96D (3)雙焦鏡片加入稜鏡組平均近視增加-0.70D。眼軸長增加平均各為0.62mm、0.41mm、0.41mm。結果的差別具有統計上的意義。




Randomized Trial of Effect of Bifocal and Prismatic Bifocal Spectacles on Myopic Progression

Two-Year Results

Desmond Cheng, OD, MSc, PhD; Katrina L. Schmid, PhD; George C. Woo, OD, MSc, PhD; Bjorn Drobe, MSc, PhD 

Arch Ophthalmol. 2010;128(1):12-19. doi:10.1001/archophthalmol.2009.332

Objective  To determine whether bifocal and prismatic bifocal spectacles could control myopia in children with high rates of myopic progression.

Methods  This was a randomized controlled clinical trial. One hundred thirty-five (73 girls and 62 boys) myopic Chinese Canadian children (myopia of 1.00 diopters [D]) with myopic progression of at least 0.50 D in the preceding year were randomly assigned to 1 of 3 treatments: (1) single-vision lenses (n = 41), (2) +1.50-D executive bifocals (n = 48), or (3) +1.50-D executive bifocals with a 3–prism diopters base-in prism in the near segment of each lens (n = 46).

Main Outcome Measures  Myopic progression measured by an automated refractor under cycloplegia and increase in axial length (secondary) measured by ultrasonography at 6-month intervals for 24 months. Only the data of the right eye were used.

Results  Of the 135 children (mean age, 10.29 years [SE, 0.15 years]; mean visual acuity, –3.08 D [SE, 0.10 D]), 131 (97%) completed the trial after 24 months. Myopic progression averaged –1.55 D (SE, 0.12 D) for those who wore single-vision lenses, –0.96 D (SE, 0.09 D) for those who wore bifocals, and –0.70 D (SE, 0.10 D) for those who wore prismatic bifocals. Axial length increased an average of 0.62 mm (SE, 0.04 mm), 0.41 mm (SE, 0.04 mm), and 0.41 mm (SE, 0.05 mm), respectively. The treatment effect of bifocals (0.59 D) and prismatic bifocals (0.85 D) was significant (P < .001) and both bifocal groups had less axial elongation (0.21 mm) than the single-vision lens group (P < .001).

Conclusions  Bifocal lenses can moderately slow myopic progression in children with high rates of progression after 24 months.

全文在此

http://archopht.ama-assn.org/cgi/content/full/128/1/12

近視控制用藥Atropine的多面觀

資料來源: 鄭永豐眼科中心

http://www.eyedrcheng.com.tw/Ortho-K.asp?OrthoKID=17

Atropine的多面觀

1. Atropine藥效持續一星期，每天點用，調節力幾乎完全抑制，遠近無法調焦、瞳孔不能收縮。 

2. Atropine被誇大療效。

根據台大的研究報告，有數項疑點。

  a. 研究過程有瑕疵：實驗組和對照組同樣以0.5% Tropicamide散朣驗光數據為開始基準點。但是實驗組在Atropine狀態下應該可以推論，基準點應該更降低0.50D以上(誤差)；對照組則因為前後散朣劑相同，可以假設沒有誤差。如此一來，所有宣稱為Atropine治療效果的度數差異，其實都可能是來自於實驗設計上的誤差值。

  b. 實驗過程退出實驗者眾多，這可以表示，療效不佳者因失望而退出，這些加深快速者的退出，在統計上已經足以影響和對照組的差鉅。

  c. 療效個別差異性極大，這在藥物學上而言已經屬於”療效不可靠的藥物”，不值得衛生署大力推廣。

  d. 藥物有反彈作用(Rebound phenomenon)，一旦停藥近視可能急速惡化。有些醫師甚至只在冬天使用，夏天改用輕微的藥以避免強光傷害，殊不知幾輪下來，度數反而急速反彈升高。

3. 對於視覺功能的危害

  a. 睫狀肌在長期廢用之下，將步入不可逆的調節功能低下或喪失：

醫師都該有一個常識，凡是肌肉如果長時間廢用，必導致肌肉萎縮甚至纖維化，而不可逆轉。對於一個斷掉的手臂，打石膏固定的期間都還要早期復健(early rehabilitation)，而且要及早拆除石膏，以免使肌肉萎縮到無法復原的程度。台大對調節肌肉的研究，包括這一項嗎？目前有限的觀察，長期廢用導致調節力永久喪失是非常可能的。

  b. 調節力無法使用，將使內聚力一併受影響：

我們知道，AC/A比例約4~6：1，如果不使用調節力而改用雙光眼鏡閱讀，調節性內聚力將減少15-18稜鏡度，而必須動用雙眼融像儲備力量來彌補。這項彌補力量最高只能到達15-18稜鏡度，所有點藥又使用雙光眼鏡的兒童，被迫以體能極限的狀態來閱讀，久而久之，容易疲勞，閱讀效率低落，甚至可能引起眼位不正(斜視)，雙眼視覺功能障礙(Binocular dysfunction)。台大甚至連雙眼視覺功能及調節內聚功能都無法檢測，如何能明白問題的嚴重性並負起研究解決的責任？ 

  c. Atropine對於閱讀能力的影響，不是以多焦眼鏡就能解決：

首先，小朋友使用多焦眼鏡必須調整頭部位置，這樣的要求有時連大人都做不到，對於頑皮的兒童，鏡架時常變形，有多麼困難可想而知。其次，b.項的說明，影響閱讀重大。再者，眼球追蹤(Saccadic eye movement)也因為藥物、調節力和內聚力的改變而可能受影響。這可以很科學的以DEM(developmental eye movement )測驗(test)來研究，台大沒做。

  d. 綜合而言，Atropine對於視覺和閱讀功能的影響，的確是藥物可能控制近視加深的原理之一：

因為閱讀困難，達到逞罰閱讀的目的，學童減少直視書本、螢幕或閱讀的時間，因而減緩部份人的近視加深速度。對於仍然強迫自己閱讀的兒童，卻可能造成壓力，反而促使度數加深或形成雙眼視覺功能障礙。這可以解釋為何研究過程，Drop out rate偏高，有效和無效者差距甚大，而平均仍能顯示有效的原因。台大並未對Atropine使用者閱讀行為的改變，做過任何研究。

  e. 臨床上許多閱讀困難的兒童在點Atropine後：

已經無法分辨其調節力和雙眼視覺功能障礙到底是原發性還是藥物所致，不停藥無法改善閱讀，停藥又怕反彈，處理上非常棘手，已經是一項公害。

  f. 世界上沒有其他國家如此廣泛且持續地推展Atropine。台灣成為世界唯一的奇蹟：

談到這一點，Atropine擁護者最常有的反應是，西洋人不懂近視。問題是，亞洲鄰國日本、韓國難道也不懂嗎?為何這個道理只有台灣的醫師懂得，而近視比例卻還節節上升?如果不是台灣醫師太聰明、太優秀，知人所不知，就是大家太容易被權威所愚弄。

4.長時間點藥對視網膜和青光眼的影響，沒有任何研究報告，30-40年後所造成國民的眼睛傷害，誰來負責。

   a. 不可逆的調節功能低下或喪失。

   b. 調節力無法使用，將使內聚力一併受影響。

   c. Atropine對於閱讀能力的影響。

   d. 停藥又怕近視度數反彈。