Comparison of a 3- and 6-mm Incision in Combined Phacoemulsification and Trabeculectomy
W. Andrew Lyle, M.D., and Jia C h i Jin, M . D .
We s t u d i e d 2 1 6 e y e s o f 1 6 0 p a t i e n t s w h o underwent combined phacoemulsification and posterior chamber intraocular lens im plantation with trabeculectomy. T h e mean f o l l o w - u p w a s 18.7 m o n t h s , w i t h a m i n i m u m f o l l o w - u p o f s i x m o n t h s . To a s s e s s t h e s a f e t y a n d efficacy o f a r e c e n t l y d e v e l o p e d 3 - m m incision procedure with foldable intraocular lens implantation (phacotrabeculectomy), we compared 104 eyes subjected to this p r o c e d u r e with 112 eyes subjected to a 6 - m m p r o c e d u r e at different f o l l o w - u p p e r i o d s . I n t r a o c u l a r pressure control « 21 m m H g ) w a s a t t a i n e d in 4 4 of 4 6 e y e s (96%) i n t h e 3 - m m g r o u p a n d 7 1 of 7 6 e y e s (93%) i n t h e 6 - m m g r o u p a t o n e y e a r postoperatively. Visual a c u i t y of 2 0 / 4 0 or bet t e r w a s a t t a i n e d i n 4 0 o f 4 6 e y e s ( 8 7 % ) in t h e 3 - m m g r o u p a n d 6 6 of 76 eyes (87%) in t h e 6 - m m group. T h e incidence of p o s t o p e r a t i v e c o m p l i c a t i o n w a s s i g n i f i c a n t l y l o w e r (P < .001) a n d v i s u a l a c u i t y in t h e e a r l y p o s t o p e r a tive period was significantly better (F < .01) in the 3 - m m incision group t h a n in the compari son group.
T H E ADVANTAGES o f c o m b i n e d s u r g e r y for c a t a ract a n d g l a u c o m a h a v e b e e n w i d e l y r e c o g n i z e d s i n c e the m i d 1 9 7 0 s . ' ' " C u r r e n t l y , t h e m o s t commonly used combined procedure is planned extracapsular cataract extraction with a posterior chamber intraocular lens implanta tion a n d trabeculectomy.^"''•" P h a c o e m u l s i f i c a tion, h o w e v e r , h a s i n c r e a s e d r a p i d l y in p o p u larity r e c e n t l y . ' ^ " S i n c e t h e i n t r o d u c t i o n o f
Accepted for publication Oct. 19, 1990. From The Eye Institute of Utah, Salt Lake City, Utah. Reprint requests to W. Andrew Lyle, M.D., The Eye Institute of Utah, 755 E. 3900 South, Salt Lake City, UT 84107.
foldable lens implantation, some interesting n e w o p t i o n s are available to anterior s e g m e n t s u r g e o n s . T o a s s e s s t h e s a f e t y a n d efficacy o f the small incision procedure, we studied the initial experience of a new 3-mm incision pro c e d u r e for c o m b i n e d p h a c o e m u l s i f i c a t i o n a n d foldable lens implantation with trabeculectomy and c o m p a r e d 1 0 4 eyes s u b j e c t e d to this proce d u r e w i t h 1 1 2 e y e s s u b j e c t e d to a 6 - m m i n c i s i o n conventional combined procedure.
Patients and Methods The combined phacoemulsification, posterior c h a m b e r i n t r a o c u l a r l e n s i m p l a n t a t i o n , a n d tra b e c u l e c t o m y w e r e p e r f o r m e d in 2 1 6 e y e s o f 1 6 0 p a t i e n t s b y o n e o f us ( W . A . L . ) b e t w e e n J a n u a r y 1 9 8 4 and D e c e m b e r 1 9 8 9 . S e v e n eyes of seven additional patients w h o u n d e r w e n t this opera tion were excluded from our analysis b e c a u s e o f l a c k o f a d e q u a t e f o l l o w - u p d a t a c o l l e c t i o n . In t h e first g r o u p , w h i c h b e g a n in 1 9 8 4 , all t h e patients received phacoemulsification with pol ymethylmethacrylate posterior c h a m b e r intra ocular lens implantation and trabeculectomy through a 6-mm incision. The trabeculectomy w a s p e r f o r m e d b y c r e a t i n g a 3 - m m flap p o s t e r i orly at o n e p o i n t in t h e i n c i s i o n . S i n c e M a r c h 1 9 8 8 , a new procedure with a 3-mm incision has b e e n used through w h i c h the p h a c o e m u l s i fication, i n t r a o c u l a r l e n s i n s e r t i o n , a n d t r a b e c ulectomy are a c c o m p l i s h e d ( p h a c o t r a b e c u l e c t o m y ) . In o u r s t u d y , 1 1 2 e y e s in t h e first g r o u p a n d 1 0 4 e y e s in t h e s e c o n d g r o u p w e r e c o m pared. T h e c r i t e r i a for s e l e c t i o n o f p a t i e n t s w e r e t h e s a m e in b o t h g r o u p s . T h o s e c h o s e n f o r c o m b i n e d surgery had cataract that affected vision s i g n i f i c a n t l y a n d g l a u c o m a at v a r i o u s s t a g e s . T h e p a t i e n t s h a d v i s u a l field d e f e c t s c o n s i s t e n t with glaucoma, o p h t h a l m o s c o p i c evidence of
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g l a u c o m a t o u s o p t i c n e u r o p a t h y , or i n t r a o c u l a r pressure of higher than 22 mm Hg while taking m e d i c a l t r e a t m e n t . S o m e o f the p a t i e n t s h a d undergone previous laser trabeculoplasty. P r e o p e r a t i v e l y , all p a t i e n t s h a d a s t a n d a r d examination including best-corrected visual acuity, applanation tonometry, gonioscopy, de tailed o p h t h a l m o s c o p i c e x a m i n a t i o n , a n d v i s u al field t e s t i n g . P r e o p e r a t i v e i n t r a o c u l a r p r e s sure was d e t e r m i n e d as the a v e r a g e o f the last three applanation tonometry measurements d u r i n g the two m o n t h s b e f o r e s u r g e r y . P o s t o p e r a t i v e f o l l o w - u p was at l e a s t six m o n t h s in both groups. Intraocular pressure, best-correct ed visual a c u i t y , n u m b e r o f m e d i c a t i o n s , a n d b l e b f o r m a t i o n w e r e r e c o r d e d at e a c h f o l l o w - u p visit. 3-mm incision procedure—After appropriate local p e r i b u l b a r a n e s t h e s i a , a 7 - 0 silk e p i s c l e r a l t r a c t i o n s u t u r e was p l a c e d as far s u p e r i o r l y on the g l o b e as p o s s i b l e . A l i m b a l - b a s e d c o n j u n c tival flap was d i s s e c t e d s u p e r i o r l y a p p r o x i m a t e ly 10 m m p o s t e r i o r to the c o r n e o s c l e r a l l i m b u s . T e n o n ' s c a p s u l e was r e m o v e d u n d e r the a r e a of the c o n j u n c t i v a l flap w i t h s c i s s o r s . T h e a r e a d e s i g n a t e d for the s c l e r a l t r a b e c u l e c t o m y flap was t r e a t e d w i t h light s u r f a c e c a u t e r y . A 3 - m m d i a m o n d k e r a t o m e b l a d e set at a d e p t h o f 0 . 3 m m was u s e d to o u t l i n e a r e c t a n g u l a r t r a b e c u l e c t o m y flap m e a s u r i n g 3 . 0 x 2 . 5 x 2 . 5 m m . T h e p o s t e r i o r e d g e o f this flap was lifted a n d d i s s e c t e d forward i n t o the c o r n e o s c l e r a l l i m b u s w i t h a c i r c u l a r b l a d e . A k e r a t o m e w a s u s e d to e n t e r the a n t e r i o r c h a m b e r a n t e r i o r l y . T h e irri gating cystotome was introduced, and a circular c a p s u l o t o m y w a s p e r f o r m e d b e g i n n i n g at t h e 4 o'clock meridian and carried counterclockwise s u p e r i o r l y to the 12 o ' c l o c k m e r i d i a n . A f t e r approximately 180 degrees of capsular tearing h a d b e e n a c h i e v e d , the flap was f o l d e d o v e r a n d t h e n p u s h e d i n f e r i o r l y w i t h the c y s t o t o m e . T h e c o n t i n u o u s tear c a p s u l o t o m y w a s t h u s c a r r i e d a r o u n d to the o r i g i n a l s t a r t i n g p o i n t at t h e 4 o ' c l o c k m e r i d i a n . T h i s left the c a p s u l a r r e m n a n t floating free in the a n t e r i o r c h a m b e r . D e spite a s m a l l pupil, a c a p s u l o t o m y m u c h l a r g e r t h a n the pupil c o u l d b e f a s h i o n e d b y u s i n g v i s c o e l a s t i c m a t e r i a l , iris r e t r a c t i o n , a n d v i s u a l c u e s . A 4 . 5 - to 5 . 0 - m m d i a m e t e r o r l a r g e r c a p s u l o t o m y w a s d e s i r e d for the s i l i c o n e l e n s i m p l a n t . P h a c o e m u l s i f i c a t i o n w i t h a 1 5 - or 3 0 d e g r e e tip was u s e d to b i s e c t the n u c l e u s w i t h progressively deeper central sculpting while s t a b i l i z i n g the n u c l e u s w i t h a 5 - m m s p a t u l a in the o t h e r h a n d . T h e s c u l p t i n g was c a r r i e d d e e p
February, 1991
er c e n t r a l l y u n t i l the p o s t e r i o r c o r t e x w a s r e a c h e d . S c u l p t i n g c o n t i n u e d further t o w a r d the 6 o ' c l o c k m e r i d i a n u n t i l the l o w e r p o l e o f the n u c l e u s was r e m o v e d . P e r i p h e r a l p o r t i o n s o f the n u c l e u s w e r e t h e n r e m o v e d b y b u r r o w i n g the p h a c o e m u l s i f i c a t i o n tip i n t o the n u c l e u s a n d b r e a k i n g away t r i a n g u l a r s e g m e n t s b e g i n n i n g at the 4 o ' c l o c k m e r i d i a n . T h e s e g m e n t s of n u c l e u s w e r e e m u l s i f i e d in the p o s t e r i o r c h a m b e r , a n d the n u c l e u s was t h e n r o t a t e d p r o g r e s sively c l o c k w i s e w i t h r e m o v a l o f t h e n e x t t r i a n g u l a r s e g m e n t u n t i l the n u c l e u s h a d b e e n d e b u l k e d to the p o i n t t h a t it c o u l d b e lifted t h r o u g h the c i r c u l a r c a p s u l o t o m y a n d emulsific a t i o n c o m p l e t e d . T h e c o r t e x was r e m o v e d b y standard irrigation and aspiration handpiece (with occasional use of a curved irrigation and a s p i r a t i o n h a n d p i e c e o f c u r v e d c a n n u l a for the 12 o ' c l o c k c o r t e x ) . T h e p o s t e r i o r c a p s u l e was v a c u u m e d at a l o w v a c u u m s e t t i n g . V i s c o e l a s t i c m a t e r i a l was i n j e c t e d i n t o the a n t e r i o r c h a m b e r . T h e s i l i c o n e i n t r a o c u l a r l e n s was p l a c e d i n t o the i n j e c t o r , a n d the s i l i c o n e s l e e v e w a s slit s e v e r a l t i m e s w i t h a b l a d e to a l l o w g e n t l e un f o l d i n g o f the l e n s in the e y e . At this p o i n t , the d e e p b l o c k o f c o r n e o s c l e r a l t i s s u e was r e m o v e d b y p a s s i n g the 3 - m m d i a m o n d b l a d e k e r a t o m e into the c h a m b e r through a second perforation s l i g h t l y p o s t e r i o r to the o r i g i n a l e n t r y . T h e d i a m o n d b l a d e w a s u s e d to r e m o v e a s e g m e n t of d e e p s c l e r a . T h e i n j e c t o r w a s i n t r o d u c e d t h r o u g h the 3 - m m i n c i s i o n , a n d the l e n s w a s s l o w l y u n f o l d e d i n t o the i n f e r i o r c a p s u l e . A d d i tional viscoelastic material was injected into the a n t e r i o r c h a m b e r to p u s h t h e u p p e r h a p t i c of the i n t r a o c u l a r l e n s p o s t e r i o r l y . A p u s h e r a n d m i c r o i r i s h o o k m a n i p u l a t e d the i m p l a n t i n t o the c a p s u l e . T h e i r r i g a t i o n a n d a s p i r a t i o n h a n d p i e c e was u s e d to r e m o v e t h e v i s c o e l a s t i c m a t e r i a l w i t h a c i r c u l a r m o t i o n in the p e r i p h e r y of the a n t e r i o r c h a m b e r first. T h i s a l l o w e d s p o n t a n e o u s rapid w a s h o u t o f m o s t o f the c e n tral p o r t i o n o f the v i s c o e l a s t i c m a t e r i a l . A l o n g , n a r r o w , p e r i p h e r a l i r i d o t o m y o r i r i d e c t o m y was p e r f o r m e d a l m o s t the e n t i r e l e n g t h o f t h e i n c i s i o n . T h e s c l e r a l flap w a s c l o s e d w i t h four to five 1 0 - 0 b l a c k n y l o n s u t u r e s . T h e c o n j u n c t i v a l i n c i s i o n was s u t u r e d w i t h a r u n n i n g 1 0 - 0 P r o lene (or 8-0 Vicryl) with a blunt v a s c u l a r - 1 0 0 n e e d l e . B a l a n c e d s a l t s o l u t i o n was i n j e c t e d i n t o the a n t e r i o r c h a m b e r w i t h a 3 0 - g a u g e c a n n u l a t h r o u g h the p a r a c e n t e s i s to i n c r e a s e the p r e s sure in the g l o b e . A n y c o n j u n c t i v a l l e a k s w e r e closed with additional sutures. Inferior subcon junctival injection of 0.3 mg of b e t a m e t h a s o n e
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was a d m i n i s t e r e d . Standard postoperative m e d i c a t i o n s c o n s i s t e d o f an a n t i b i o t i c - c o r t i c o s t e r o i d e y e d r o p four t o s i x t i m e s d a i l y . 6-mm incision procedure—A 6-mm incision w i t h a c e n t r a l t r a b e c u l e c t o m y flap w a s u s e d . A C - l o o p or J - l o o p 6 - m m polymethylmeth acrylate posterior c h a m b e r intraocular lens with 5 - 0 p o l y p r o p y l e n e h a p t i c s w a s u s e d in t h i s procedure. Otherwise, the technique was the s a m e as t h e 3 - m m i n c i s i o n p r o c e d u r e . The preoperative and postoperative care were t h e s a m e in b o t h g r o u p s . S u r g e r y w a s p e r formed on an outpatient basis and no hospitali z a t i o n w a s n e c e s s a r y in e i t h e r g r o u p . Patients were discharged on the operative day a n d w e r e e x a m i n e d on t h e first p o s t o p e r a tive day a n d a g a i n at t h e e n d o f t h e first p o s t o p erative week. Additional follow-up visits were dictated by the clinical course. T h e patients i n c l u d e d in t h i s s t u d y w e r e f o l l o w e d up f o r at l e a s t six m o n t h s after t h e o p e r a t i o n . The topical antibiotic-corticosteroid eye drops were gradually discontinued over a sixw e e k p e r i o d . I f a d e q u a t e filtration or sufficient ly l o w i n t r a o c u l a r p r e s s u r e w a s n o t a t t a i n e d after t h e first four to five days, s u t u r e s w e r e c u t o n e at a t i m e w i t h a n a r g o n l a s e r a n d a n y l o n suture cutting lens. Digital compression by the p a t i e n t for ten s e c o n d s t h r e e t i m e s daily w a s recommended if necessary. Data were analyzed statistically using test. F i s h e r ' s e x a c t test, a n d m u l t i v a r i a t e a n a l y s i s o f v a r i a n c e for r e p e a t e d m e a s u r e s .
Results The 3-mm phacotrabeculectomy procedure was p e r f o r m e d in 1 0 4 e y e s o f 8 3 p a t i e n t s , a n d the 6 - m m c o m b i n e d p r o c e d u r e w a s p e r f o r m e d in 1 1 2 e y e s o f 7 7 p a t i e n t s . T h e t w o g r o u p s w e r e s i m i l a r w i t h r e s p e c t to a g e ( m e a n , 7 5 . 5 y e a r s ; r a n g e , 2 9 to 9 7 y e a r s ) , s e x ( 6 5 m e n a n d 9 5 women), and type of glaucoma ( 1 6 6 of 2 1 6 eyes [ 8 1 . 9 % ] with primary open-angle glaucoma). T h e d u r a t i o n o f p o s t o p e r a t i v e f o l l o w - u p in t h e 3-mm group (mean, 1 1 . 2 m o n t h s ; range, six to 2 5 m o n t h s ) w a s s h o r t e r t h a n in t h e 6 - m m g r o u p ( m e a n , 2 6 . 2 m o n t h s ; r a n g e , six t o 6 2 m o n t h s ) (Table 1 ) . The average preoperative intraocular pres sure w a s 2 3 m m Hg in b o t h g r o u p s , w i t h 5 5 o f t h e 1 0 4 e y e s ( 5 2 . 8 % ) in t h e 3 - m m g r o u p h a v i n g
TABLE 1 PATIENT CHARACTERISTICS 3-MM INCISION 6-MM INCISION PROCEDURE PROCEDURE
Number of patients Eyes Age (yrs) l^ean Range Older than 80 years Sex (M/F) Follow-up (mos) Mean Range Subtypes of glaucoma Primary open-angle Pseudoexfoliation Pigmentary Combined mechanism Chronic angle-closure Trauma-Induced
TOTAL
83 104
77 112
160 216
76 38-92 31 36/47
75 29-97 30 29/48
75.5 29-97 61 65/95
11.2 6-25
26.2 6-62
18.7 6-62
81 13 3 2 5 0
96 11 0 2 1 2
177 24 3 4 6 2
i n t r a o c u l a r p r e s s u r e g r e a t e r t h a n 2 2 m m Hg, a n d 6 8 o f t h e 1 1 2 e y e s ( 6 0 . 7 % ) in t h e 6 - m m group having intraocular pressure greater than 2 2 m m Hg. E l e v e n e y e s in t h e 3 - m m g r o u p a n d five e y e s in t h e 6 - m m g r o u p h a d u n d e r g o n e previous laser trabeculoplasty. T h e average postoperative intraocular pressure was 16.3 m m Hg at o n e day, 1 5 . 9 m m Hg at o n e w e e k , 1 4 . 3 m m Hg at s i x m o n t h s , 1 5 . 3 m m Hg at o n e y e a r , a n d 1 4 . 3 m m Hg at t w o y e a r s in t h e 3 - m m group (Figure). A m u l t i v a r i a t e a n a l y s i s of v a r i a n c e for r e p e a t e d m e a s u r e s w a s p e r f o r m e d on t h e i n t r a o c u l a r pressure measurements. Intraocular pressure o f p a t i e n t s i n c l u d e d in t h e a n a l y s i s w a s m e a s u r e d at e a c h v i s i t t h r o u g h six m o n t h s . A sig nificant d i f f e r e n c e w a s f o u n d b e t w e e n p r e operative intraocular pressure and average p o s t o p e r a t i v e i n t r a o c u l a r p r e s s u r e (P < . 0 0 1 ) . There was no significant difference between p r o c e d u r e g r o u p s (P = . 7 4 4 ) . H o w e v e r , s i g n i f i c a n t d i f f e r e n c e s w e r e f o u n d in t h e p a t t e r n e x h i b i t e d b e t w e e n p r o c e d u r e s o v e r t i m e (P = . 0 1 2 ) . T h i s i n t e r a c t i o n s h o w e d t h a t e y e s in t h e 6-mm procedure group had lower intraocular p r e s s u r e i n i t i a l l y , b u t e y e s in t h e 3 - m m p r o c e dure group ultimately had lower intraocular p r e s s u r e ( T a b l e 2 ) . At t h e first p o s t o p e r a t i v e day, t e n o f 1 0 4 e y e s ( 9 . 6 % ) in t h e 3 - m m g r o u p a n d s e v e n o f 1 1 2 e y e s ( 6 . 3 % ) in t h e 6 - m m g r o u p
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Figure (Lyle and Jin). Intraocular pressure at different follow-up periods for 3-mm and 6-nim groups. Note that the 3-mm proce dure had lower intraocular pressure ulti mately.
o 6mm procedure
o < α:
O
• 3 mm procedure 1
pre
1
I day
Iwk
6mo
lyr
2yr
FOLLOW UP TIME had intraocular pressure greater than 3 0 m m Hg. At the o n e - y e a r f o l l o w - u p visit, 4 4 o f 4 6 e y e s ( 9 6 % ) in t h e 3 - m m g r o u p a n d 71 o f 7 6 e y e s ( 9 3 % ) in the 6 - m m g r o u p h a d i n t r a o c u l a r p r e s sure o f less t h a n or e q u a l to 21 m m Hg ( T a b l e 3 ) . The number of antiglaucoma medications be fore a n d after s u r g e r y is s h o w n in T a b l e 4 . A s u b s t a n t i a l d e c r e a s e in the n u m b e r o f m e d i c a t i o n s after s u r g e r y o c c u r r e d . P r e o p e r a t i v e l y , 9 6 o f 1 0 4 e y e s ( 9 2 . 3 % ) in t h e 3 - m m g r o u p r e q u i r e d m e d i c a t i o n . At six m o n t h s a n d o n e y e a r p o s t o p -
TABLE 2 INTRAOCULAR PRESSURE CHANGE AFTER SURGERY* CHANGE IN INTRAOCULAR PREOPERATIVE
PRESSURE (MM HG)
INTRAOCULAR
AVERAGE
PRESSURE
DAY
WEEK
MONTH
CHANGE FOR
PROCEDURE
(MM HG)
1
1
6
PROCEDURE
3-mm Incision (N=94) 6-mm Incision (N=97) Average change at time period (N=191)
23.10
-7.78 -7.61 -8.95
-8.11
23.00
-9.86 -6.74 -6.79
-7.79
-8.82 -7.17 -7.87
-7.95
•The Ρ values were as follows: procedure, Ρ = .744: constant, Ρ = .0001; effect, Ρ = .137; and Ρ χ Ε, Ρ = .012.
eratively, 82 of 104 eyes ( 7 8 . 8 % ) and 3 6 of 4 6 e y e s ( 7 8 . 3 % ) did n o t r e q u i r e m e d i c a t i o n s to c o n t r o l i n t r a o c u l a r p r e s s u r e , r e s p e c t i v e l y . In t h e 6 - m m g r o u p , 1 0 9 of 1 1 2 e y e s ( 9 6 . 4 % ) r e q u i r e d p r e o p e r a t i v e m e d i c a t i o n . At six m o n t h s and o n e year postoperatively, 6 8 of 1 1 0 eyes ( 6 1 . 8 % ) a n d 4 4 o f 7 6 e y e s ( 5 7 . 9 % ) did n o t r e q u i r e m e d i c a t i o n s to c o n t r o l i n t r a o c u l a r p r e s s u r e , r e s p e c t i v e l y . T h e r e w a s a s i g n i f i c a n t dif ference regarding the medication between t h e s e t w o g r o u p s at t h e o n e - y e a r p o s t o p e r a t i v e p e r i o d (P < . 0 5 ) ( T a b l e 4 ) . At t h e first p o s t o p e r a t i v e day, 2 9 of 1 0 4 e y e s ( 2 7 . 9 % ) in the 3 - m m g r o u p h a d v i s u a l a c u i t y o f 2 0 / 4 0 or b e t t e r , c o m p a r e d to 1 4 of 1 1 2 e y e s ( 1 2 . 5 % ) in t h e 6 - m m g r o u p . T h e r e w a s a signifi c a n t d i f f e r e n c e b e t w e e n t h e s e t w o g r o u p s (P < . 0 1 ) . At t h e s i x - m o n t h visit, 8 9 of 1 0 4 e y e s ( 8 5 . 6 % ) in the 3 - m m g r o u p h a d 2 0 / 4 0 v i s u a l a c u i t y or b e t t e r a s c o m p a r e d to 8 7 of 1 1 2 e y e s ( 7 7 . 7 % ) in t h e 6 - m m g r o u p . At the 1 2 - m o n t h p o s t o p e r a t i v e i n t e r v a l , 4 0 o f 4 6 e y e s ( 8 7 % ) in t h e 3 - m m g r o u p a n d 6 6 o f 7 6 e y e s ( 8 7 % ) in t h e 6 - m m g r o u p h a d v i s u a l a c u i t y o f 2 0 / 4 0 or better (Table 5 ) . T h e r e w e r e six e y e s in t h e 3 - m m g r o u p a n d e i g h t e y e s in t h e 6 - m m g r o u p that r e t a i n e d t h e s a m e v i s u a l a c u i t y as p r e o p e r a t i v e l y or d e t e r i o r a t e d at t h e final f o l l o w - u p v i s i t . T h e m e a n f o l l o w - u p t i m e w a s n i n e m o n t h s in t h e 3 - m m g r o u p a n d 4 5 m o n t h s in t h e 6 - m m g r o u p . A m o n g those 14 eyes with visual acuity worse t h a n 2 0 / 2 0 0 , f o u r w e r e b e l i e v e d to h a v e c e n t r a l vision involvement by advanced glaucoma pre operatively, eight had age-related macular de generation, one had central retinal vein occlu sion, and one had cystoid macular edema.
Vol, 111, No, 2
Combined Phacoemulsification and Trabeculectomy
193
TABLE 3 I N T R A O C U L A R P R E S S U R E C O N T R O L AT E A C H F O L L O W - U P V I S I T
3-MM PROCEDURE
6-MM PROCEDURE
PREOPERATIVE
6 MONTH
12 MONTH
24 MONTH
PREOPERATIVE
6 MONTH
1 2 MONTH
24 MONTH
(N = 104)
(N = 104)
(N = 46)
(N = 14)
(N = 112)
(N = 110)
(N = 76)
(N = 63)
PRESSURE
NO. (%)
NO, (%)
NO. (%)
NO. (%)
NO. (%)
NO. (%)
NO. (%)
NO. (%)
< 21 mm Hg > 22 mm Hg
49 (47.1) 55 (52.9)
102 (98) 2(1.9)
44 (95.6) 2 (4.3)
14(100) 0 (0.0)
44 (39.3) 68 (60.7)
105(95.4) 5 (4.5)
71 (93.4) 5 (6.6)
58 (92.1) 5 (7.9)
INTRAOCULAR
A d e t e c t a b l e c o n j u n c t i v a l filtering b l e b w a s s e e n in 2 2 of 1 0 4 e y e s ( 2 1 . 1 % ) in t h e 3 - m m g r o u p a n d 2 7 o f 1 1 0 e y e s ( 2 4 . 5 % ) in t h e 6 - m m g r o u p at t h e s i x - m o n t h visit, a n d in n i n e of 4 6 e y e s ( 1 9 . 5 % ) in t h e 3 - m m g r o u p a n d t e n o f 7 6 e y e s ( 1 3 . 2 % ) in t h e 6 - m m g r o u p at t h e 1 2 m o n t h visit. N o s t a t i s t i c a l d i f f e r e n c e w a s n o t e d b e t w e e n t h e two g r o u p s (P > . 9 8 at six m o n t h s a n d Ρ > . 3 0 at 1 2 m o n t h s ) .
6 - m m g r o u p a n d in n o n e o f t h e e y e s in t h e 3-mm group, and cystoid macular edema oc c u r r e d in o n e e y e in t h e 3 - m m g r o u p a n d four e y e s in t h e 6 - m m g r o u p ( T a b l e 6 ) .
The most frequent complication was tran sient postoperative hyphema, which occurred in 15 o f 1 0 4 e y e s ( 1 4 . 4 % ) in t h e 3 - m m g r o u p a n d 3 0 o f 1 1 2 e y e s ( 2 6 . 8 % ) in t h e 6 - m m g r o u p . All s p o n t a n e o u s l y c l e a r e d w i t h i n s e v e n days w i t h o u t d e t r i m e n t a l effect. A s t a t i s t i c a l l y sig nificant d i f f e r e n c e w a s n o t e d b e t w e e n t h e t w o g r o u p s (P = . 0 3 9 ) . P o s t e r i o r c a p s u l a r o p a c i f i c a t i o n that r e q u i r e d N d : Y A G p o s t e r i o r c a p s u l o t o m y o c c u r r e d in t e n e y e s ( 9 . 6 % ) in t h e 3 - m m g r o u p a n d 2 0 e y e s ( 1 7 . 9 % ) in t h e 6 - m m g r o u p (P = . 1 2 0 ) . P o s t o p e r a t i v e c h o r o i d a l effusion o c c u r r e d in t h r e e o f 1 0 4 e y e s ( 2 . 3 % ) in t h e 3 - m m g r o u p , w h i c h w a s s i g n i f i c a n t l y l o w e r as c o m p a r e d w i t h 13 of 1 1 3 e y e s ( 1 1 . 6 % ) in t h e 6 - m m g r o u p (P = . 0 2 9 ) . T h e c h o r o i d a l effusion w a s r e a d i l y a b s o r b e d w i t h i n t h r e e w e e k s in all p a t i e n t s after c o r t i c o s t e r o i d a n d c y c l o p l e g i c treatment without surgical intervention. Pos t e r i o r s y n e c h i a e d e v e l o p e d in four e y e s in t h e
T h e s u r g i c a l t r e a t m e n t of c a t a r a c t in p a t i e n t s w i t h g l a u c o m a h a s c h a n g e d b e c a u s e of t h e widespread use of extracapsular extraction, posterior chamber intraocular lens implanta tion, and t r a b e c u l e c t o m y . ' " Recently, these techniques have b e e n modified with the resur g e n c e o f p h a c o e m u l s i f i c a t i o n , ' ^ ' " w h i c h we h a v e u s e d in c o m b i n e d c a t a r a c t a n d g l a u c o m a procedures since 1 9 8 4 . We have performed a new 3-mm incision procedure using phaco emulsification, foldable lens implantation, and t r a b e c u l e c t o m y in o u r p a t i e n t s s i n c e 1 9 8 8 . T h e p o s t o p e r a t i v e r e s u l t s o f 1 0 4 e y e s in t h e 3 - m m i n c i s i o n g r o u p a n d 1 1 2 e y e s in t h e 6 - m m p r o c e d u r e g r o u p w e r e e n c o u r a g i n g in c o m p a r i s o n to p r e v i o u s s t u d i e s w i t h p l a n n e d e x t r a c a p sular extraction and trabeculectomy. T h e longt e r m i n t r a o c u l a r p r e s s u r e c o n t r o l w a s s i m i l a r in our t w o g r o u p s , w i t h m e a n p r e o p e r a t i v e i n t r a o c u l a r p r e s s u r e o f 2 3 m m Hg in b o t h g r o u p s ;
Discussion
TABLE 4 ANTIGLAUCOMA MEDICATION
3-MM PROCEDURE
6-MM PROCEDURE
PREOPERATIVE
6 MONTH
12 MONTH
24 MONTH
PREOPERATIVE
6 MONTH
12 MONTH
24 MONTH
(N = 104)
(N = 104)
(N = 46)
(N = 14)
(N = 112)
(N = 110)
(N = 76)
(N = 63)
MEDICATIONS
NO. (%)
NO. (%)
NO. (%)
NO, (%)
NO. (%)
NO. (%)
NO, (%)
NO. (%)
0 1 2 3 or more
8 (7.7) 67 (64.4) 25 (24.0) 4 (3.8)
82 (78.8) 20 (19.2) 2(1.9) 0
36 (78.3) 8 (17.4) 2 (4.3) 0
8 (57.1) 4 (28.6) 2 (14.3) 0
4 (3.6) 62 (55.4) 36(32.1) 10 (8.9)
68 (61.8) 36 (32.7) 6 (5.5) 0
44 (57.9) 26 (34.2) 6 (7.9) 0
30 (47.6) 29 (46.0) 4 (6.3) 0
NO, OF
194
February, 1991
AMERICAN JOURNAL OF OPHTHALMOLOGY
TABLE 5 PREOPERATIVE AND POSTOPERATIVE VISUAL ACUITY 3-MM PROCEDURE
VISUAL
6-MM PROCEDURE
PREOPERATIVE 1 DAY 1 WEEK 6 MONTHS 1 YEAR 2 YEARS PREOPERATIVE 1 DAY 1 WEEK 6 MONTHS 1 YEAR 2 YEARS (N=104) (N = 104) (N = 100) (N = 104) (N = 46) (N = 14) (N = 112) (N = 112) (N = 103) (N = 110) (N = 76) (N = 63)
ACUITY-
N0.(%)
NO. (%)
NO. (%)
20/25 20/3020/40 20/5020/70 20/8020/100 20/200CF HMor worse
0 21 (20.2)
9(8.7) 17(17.0) 54(51.9) 23(50.0) 9(57.1) 20 (19.2) 35 (35.0) 35 (33.7) 17 (37.0) 5 (35.7)
1(0.9) 11 (9.8)
1(0.89) 9(8.7) 47(42.7) 38(50.0) 28(44.4) 13 (11.6) 29 (28.2) 40 (36.4) 28 (36.8) 28 (36.5)
53(51.0)
25(24.0) 23(23.0) 10(9.6)
2(4.3) 0
63 (56.3)
24(21.4) 29(28.2) 17(15.5)
5(6.6)
6(9.5)
13(2.5)
10(9.6) 10(10.0)
0
1 (2.2) 1(7.1)
17(15.2)
17(15.2)10(9.7)
3(2.7)
1(1.3)
2(3.2)
14(13.5)
36(34.6) 13(13.0)
5(4.8)
3(6.5) 0
16(14.3)
34(30.4)17(16.5)
3(3.7)
3(3.9)
3(4.8)
1 (0.9)
0
4(3.6)
23(20.5) 9(8.7)
4(3.6)
1 (1.3)
1(1.6)
3(2.9)
NO. (%)
4(3.8)
N0.(%)
2(2.0)
NO. (%)
NO. (%)
0
NO. (%)
NO. (%)
NO. (%)
NO. (%)
NO. (%)
*CF indicates counting fingers and HM indicates hand motions.
1 4 . 3 m m Hg at six m o n t h s , 1 5 . 8 m m Hg at o n e y e a r , a n d 1 4 . 3 m m Hg at two y e a r s in t h e 3 - m m g r o u p ; a n d 1 5 . 8 m m Hg at six m o n t h s , 1 7 . 5 m m Hg at o n e year, a n d 1 6 . 1 m m Hg at two y e a r s in the 6-mm group. These results were consistent w i t h that of M u r c h i s o n a n d S h i e l d s ^ ( m e a n baseline intraocular pressure, 18 mm Hg; m e a n final i n t r a o c u l a r p r e s s u r e , 1 4 . 7 m m H g ) , a n d M c C a r t n e y a n d a s s o c i a t e s ' ( m e a n b a s e l i n e in t r a o c u l a r p r e s s u r e , 2 3 m m Hg; m e a n final i n t r a o c u l a r p r e s s u r e , 1 7 . 1 m m H g ) . In t h e p r e s e n t study, at o n e year, 3 6 o f 4 6 e y e s ( 7 8 . 3 % ) at t a i n e d i n t r a o c u l a r p r e s s u r e c o n t r o l ( £ 21 m m Hg) on n o m e d i c a t i o n , 1 7 . 4 % w e r e c o n t r o l l e d
on o n e m e d i c a t i o n , a n d 4 . 3 % h a d i n t r a o c u l a r p r e s s u r e o f 2 2 m m Hg in t h e 3 - m m g r o u p . In c o m p a r i s o n to t h e 6 - m m g r o u p a n d t h e s t u d y o f M c C a r t n e y a n d a s s o c i a t e s ' ( b o t h h a d 5 7 % of e y e s s 2 1 m m Hg w i t h o u t m e d i c a t i o n ) , t h e r e w e r e fewer m e d i c a t i o n s n e e d e d to c o n t r o l i n t r a o c u l a r p r e s s u r e in t h e 3 - m m g r o u p . T h e 6-mm procedure had lower intraocular pres sure initially, but the 3 - m m procedure ulti mately showed lower intraocular pressure. There was obvious i m p r o v e m e n t of visual a c u i t y in b o t h g r o u p s c o m p a r e d to t h e p r e o p e r ative v i s i o n . At o n e y e a r after s u r g e r y , 8 7 % o f e y e s in b o t h g r o u p s ( 4 0 o f 4 6 e y e s in t h e 3 - m m
TABLE 6 COMPLICATION 3-MM INCISION (N = 104)
6-MM PROCEDURE (N = 112)
COMPLICATIONS
NO.
(%)
NO.
(%)
DIFFERENCE
Hyphema Shallow anterior ctiamber Posterior chamber opacification requiring YAG posterior capsulotomy Ctioroidal detachment Intraocular pressure increase (s: 30 mm Hg) Hypotony (rs 4 mm Hg) Cystoid macular edema Posterior synechiae No complication
15 3 10
(14.4) (2.9) (9.6)
30 17 20
(26.8) (15.2) (17.9)
Ρ = .03866 Ρ = .00398 Ρ = .12038
3 10 3 1 0 56
(2.9) (9.6) (2.9) (0.9) (0) (53.8)
13 7 15 4 4 30
(11-6) (6.3) (13.4) (3.6) (3.6) (26.8)
Ρ Ρ Ρ Ρ Ρ Ρ
= = = = = =
.02883 .51573 .01091 .3709 .123 .0001
Vol. I l l , No. 2
Combined Phacoemulsification and Trabeculectomy
g r o u p a n d 6 6 o f 7 6 e y e s in the 6 - m m g r o u p ) a t t a i n e d v i s u a l a c u i t y o f 2 0 / 4 0 or b e t t e r . T h i s finding is f a v o r a b l e c o m p a r e d to S i m m o n s a n d a s s o c i a t e s / w h o noted that 33 of 5 5 eyes ( 6 0 % ) o f t h e i r p a t i e n t s h a d v i s u a l a c u i t y o f 2 0 / 4 0 or b e t t e r at o n e year, a n d M u r c h i s o n a n d S h i e l d s , ^ w h o f o u n d t h a t 17 o f 2 2 e y e s ( 7 7 % ) o f t h e i r p a t i e n t s a t t a i n e d v i s u a l a c u i t y o f 2 0 / 5 0 or b e t ter w i t h a l i m b a l - b a s e d c o n j u n c t i v a l flap. At t h e first p o s t o p e r a t i v e day, 2 7 . 9 % ( 2 9 e y e s ) in t h e 3 - m m g r o u p a n d 1 2 . 5 % ( 1 4 e y e s ) in t h e 6 - m m g r o u p h a d v i s u a l a c u i t y of 2 0 / 4 0 or b e t t e r . There was a significant difference b e t w e e n t h e s e two g r o u p s (P < . 0 1 ) . T h e 3 - m m i n c i s i o n procedure provided better visual acuity than the 6 - m m i n c i s i o n in t h e e a r l y p o s t o p e r a t i v e stage. A m o n g the 14 patients with worse visual acuity, 5 7 % (eight eyes) had age-related macu lar d e g e n e r a t i o n a n d 2 8 . 5 % (four e y e s ) h a d advanced glaucoma damage that existed preop eratively. The 3-mm incision has theoretical advantag es over l a r g e i n c i s i o n s u r g e r y i n c l u d i n g d e creased astigmatism, better uncorrected visual acuity, more rapid stabilization of refraction, shorter operating time, and more rapid healing. In our s e r i e s , v i s u a l a c u i t y o n t h e first p o s t o p e r ative day w a s s i g n i f i c a n t l y b e t t e r in t h e 3 - m m g r o u p (with v i s u a l a c u i t y o f 2 0 / 4 0 or b e t t e r in 2 7 . 9 % a n d 1 2 . 5 % o f e y e s in e a c h g r o u p , r e s p e c tively; Ρ < . 0 1 ) , a n d t h e i n c i d e n c e of e a r l y c o m p l i c a t i o n s w a s m u c h l e s s (P < . 0 0 1 ) . P a t i e n t d i s c o m f o r t w a s r a r e , all o f o u r p a t i e n t s w e r e t r e a t e d on an o u t p a t i e n t b a s i s , a n d n o p a t i e n t had severe complications caused by early dis charge and early activities. P o s t o p e r a t i v e h y p h e m a is t h e m o s t c o m m o n c o m p l i c a t i o n in c o m b i n e d s u r g e r y . T h e fixed a n d i m m o b i l e p u p i l from p r o l o n g e d m i o t i c t h e r a p y m a y r e s u l t in b l e e d i n g c a u s e d b y iris stretching and trauma during cataract extrac tion.* B l e e d i n g c a n a l s o o c c u r from t h e c o r n e o s c l e r a l i n c i s i o n or t h e iris. T h e i n c i d e n c e o f h y p h e m a h a s v a r i e d in p u b l i s h e d r e p o r t s . S i m mons and associates* reported a h y p h e m a rate of 4 5 % , w i t h 7 1 % o f h y p h e m a s o c c u r r i n g in l i m b a l - b a s e d flaps a n d 30°/o o c c u r r i n g in f o r n i x b a s e d flaps. M u r c h i s o n a n d S h i e l d s ^ r e p o r t e d that h y p h e m a o c c u r r e d in 2 8 % o f t h e i r p a t i e n t s after c o m b i n e d s u r g e r y , w h i c h is s i m i l a r to the findings in our 6 - m m g r o u p in w h i c h 3 0 e y e s ( 2 6 . 8 % ) h a d h y p h e m a . In t h e s m a l l i n c i s i o n g r o u p , h o w e v e r , o n l y 15 e y e s ( 1 4 . 4 % ) h a d h y phema during the early postoperative course. There was a significant difference between t h e s e two g r o u p s (P = . 0 3 9 ) . O n e p a t i e n t in t h e
195
3-mm incision group developed a hyphema after s u t u r e c u t t i n g w i t h t h e a r g o n l a s e r . T h e rate o f p o s t e r i o r c a p s u l a r o p a c i f i c a t i o n r e q u i r i n g c a p s u l o t o m y w a s 1 7 . 9 % ( 2 0 of 1 1 2 e y e s ) in t h e 6 - m m i n c i s i o n g r o u p , w h i c h a g r e e d w i t h p r e v i o u s studies,^* b u t it w a s r e d u c e d in the small incision group with a rate of 9 . 6 % (ten of 1 0 4 e y e s ) . C h o r o i d a l d e t a c h m e n t s o c c u r f r e q u e n t l y af ter g l a u c o m a p r o c e d u r e s d u r i n g t h e e a r l y p o s t o p e r a t i v e period'",'*"'* w h e n h y p o t o n y p e r m i t s t r a n s u d a t i o n o f fluid a c r o s s t h e c a p i l l a r y w a l l s of the choroid and c o l l e c t s on the potential space b e t w e e n uvea and sclera.'* This may re sult in a s h a l l o w or flat a n t e r i o r c h a m b e r . C h o r o i d a l d e t a c h m e n t o c c u r r e d in s i x e y e s ( 6 % ) with c o m b i n e d surgery in the report of M c C a r t n e y a n d a s s o c i a t e s . ' In o u r s e r i e s , t h r e e e y e s ( 2 . 9 % ) a n d 13 e y e s ( 1 1 , 6 % ) h a d c h o r o i d a l d e t a c h m e n t in the 3 - m m incision group and the 6-mm incision procedure group, respectively. T h e p r e v a l e n c e o f s h a l l o w or flat a n t e r i o r c h a m b e r o c c u r r i n g after c o m b i n e d s u r g e r y h a s been previously reported as being between 5 % a n d 2 6 % . ' * We f o u n d a s i g n i f i c a n t d i f f e r e n c e between the 3-mm incision group and 6-mm incision group ( 2 . 9 % and 1 5 . 2 % , respectively; Ρ = .004). The c o m b i n e d procedure may benefit pa tients with glaucoma and cataract by protection against severe early intraocular pressure in crease.* S i m m o n s a n d a s s o c i a t e s * r e p o r t e d t h a t 3 6 % of patients h a d early postoperative intra ocular pressure greater than 30 mm Hg and 4 0 % h a d i n t r a o c u l a r p r e s s u r e 7 m m Hg a b o v e their preoperative level despite c o m b i n e d sur g e r y , c o m p a r e d to t h e r e p o r t e d i n c i d e n c e o f up to 7 2 % in p a t i e n t s w i t h g l a u c o m a u n d e r g o i n g c a t a r a c t s u r g e r y alone.* M c C a r t n e y a n d a s s o c i a t e s ' s h o w e d that 5 % o f t h e i r c o m b i n e d s u r g e r y patients had intraocular pressure increase of 35 m m Hg, a n d M u r c h i s o n a n d S h i e l d s ^ n o t e d 8.5% of eyes had intraocular pressure increase g r e a t e r t h a n 3 0 m m Hg in t h e e a r l y p o s t o p e r a tive p e r i o d . In o u r s t u d y , t h e r e w e r e t e n o f 1 0 4 eyes ( 9 . 6 % ) and seven of 1 1 2 eyes ( 6 . 3 % ) that had intraocular pressure increase ( s 30 mm H g ) in t h e 3 - m m i n c i s i o n g r o u p a n d 6 - m m p r o c e d u r e g r o u p at t h e first p o s t o p e r a t i v e day, respectively. The highest intraocular pressure, 6 6 m m Hg, o c c u r r e d in a n e y e t h a t r e c e i v e d intensive treatment with 2 0 % mannitol intrave nous injection and acetazolamide intravenous i n j e c t i o n , a n d i n t r a o c u l a r p r e s s u r e d e c r e a s e d to 17 m m Hg t h e n e x t day a n d w a s c o n t r o l l e d w e l l afterward.
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In our s e r i e s , the p r e s e n c e o f a d e t e c t a b l e c o n j u n c t i v a l filtering b l e b p o s t o p e r a t i v e l y w a s f a v o r a b l e c o m p a r e d w i t h p r e v i o u s s t u d i e s . In the study o f M u r c h i s o n a n d S h i e l d s , ^ o n l y 2 3 % to 2 4 % of e y e s h a d filtering b l e b s at two m o n t h s postoperatively. S i m m o n s and associates" re p o r t e d 1 2 % o f e y e s h a d d e t e c t a b l e b l e b s at 1 2 m o n t h s . In our s e r i e s , 2 2 e y e s ( 2 1 . 1 % ) in t h e 3 - m m i n c i s i o n g r o u p a n d 2 7 e y e s ( 2 4 . 5 % ) in t h e 6-mm incision group had detectable filtering b l e b s at six m o n t h s , a n d n i n e e y e s ( 1 9 . 6 % ) in t h e 3 - m m g r o u p a n d ten e y e s ( 1 3 . 2 % ) in t h e 6 - m m g r o u p h a d b l e b s at 1 2 m o n t h s . O n e o f the c o m m o n p r o b l e m s w i t h c o m b i n e d c a t a r a c t a n d g l a u c o m a s u r g e r y is t h e m i o t i c pupil. In our s e r i e s , w e p e r f o r m e d t h e t e c h n i q u e of c i r c u l a r c a p s u l o t o m y w i t h a c a p s u l a r phacoemulsification without further modifica t i o n . It is p o s s i b l e to u s e p h a c o e m u l s i f i c a t i o n on a p u p i l m e a s u r i n g 2 . 7 5 m m , b u t t h i s c a n b e tedious. Alternatives include multiple sphinc t e r o t o m i e s at t h e pupil, radial i r i d o t o m y w i t h o r w i t h o u t r e s u t u r e o f the iris, a n d s m a l l s e c t o r iridectomy. Multiple sphincterotomies can be d o n e with or w i t h o u t v i s c o e l a s t i c m a t e r i a l b y m a k i n g s m a l l i n c i s i o n s in t h e p u p i l in e n o u g h l o c a t i o n s to dilate the p u p i l a d e q u a t e l y . A r a d i al i r i d o t o m y is c a r r i e d out after first p e r f o r m i n g a p e r i p h e r a l i r i d e c t o m y . T h e iris p i l l a r s a r e swept a s i d e for p h a c o e m u l s i f i c a t i o n a n d c a n then be resutured with 1 0 - 0 polypropylene if d e s i r e d . A s m a l l s e c t o r i r i d e c t o m y is d o n e b y introducing viscoelastic material into the ante rior c h a m b e r , f o l l o w e d by s e v e r a l a p p l i c a t i o n s of a D e s c e m e t m e m b r a n e p u n c h at t h e s u p e r i o r m a r g i n o f t h e iris. T h i s a l l o w s e n l a r g e m e n t of the p u p i l a n d g i v e s g o o d c o s m e t i c r e s u l t s p o s t operatively.
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