The South Asian cataract management study: complications, vision outcomes, and corneal endothelial cell loss in a randomized multicenter clinical trial comparing intracapsular cataract extraction with and without anterior chamber intraocular lens implantation.
OBJECTIVE
To determine clinical outcomes of primary intracapsular cataract surgery with and without implantation of anterior chamber lenses.


METHODS
A multicenter randomized clinical trial.


METHODS
One thousand two hundred twenty-nine male and female patients 40-75 years of age with senile cataract.


METHODS
Study patients were recruited from screening eye camps and outpatient clinics. Randomization to the two treatment groups was performed after screening for predetermined inclusion and exclusion criteria. Demographics, visual acuity, intraocular pressures, and corneal endothelial cell data were recorded before surgery and at 6 weeks, 12 months, and 24 months after surgery. Monitoring of the study was secured by a standardized image documentation procedure on all patients using the IMAGEnet digital imaging system. Analysis of corneal endothelial cell images was performed with the Cell Soft software (Topcon Corporation, Japan).


METHODS
Visual acuity and central corneal endothelial cell loss.


RESULTS
The patients were randomized to intraocular lens (IOL; n = 616) and no IOL (n = 613) implantation. Surgical complications were reported in 177 (14.4%) patients (IOL = 14.8%; no IOL = 14.0%). The most frequent complication observed was vitreous loss which occurred in 10.3% of eyes (IOL = 11.2%; no IOL = 9.5%). At the final examination (2 years after surgery), 88% of the operated eyes had a best corrected vision of 6/18 or better (IOL = 88.8%; no IOL = 86.6%). Analysis of corneal endothelial cell data showed a small but significantly greater cell loss 6 weeks after surgery in eyes with IOL compared with those without IOL, but no overall difference was found between the treatment groups in the long term follow-up.


CONCLUSIONS
The findings indicate that there is a rationale for the use of anterior chamber intraocular lenses in primary intracapsular cataract surgery.
Snellingen
T
T
Department of Ophthalmology, Institute of Clinical Medicine, University of Tromsø, Norway.
Shrestha
J K
JK
Huq
F
F
Husain
R
R
Koirala
S
S
Rao
G N
GN
Pokhrel
R P
RP
Kolstad
A
A
Upadhyay
M P
MP
Apple
D J
DJ
Arnesen
E
E
Cheng
H
H
Olsen
E G
EG
Vogel
M
M
D000328:Adult; D000368:Aged; D000867:Anterior Chamber / Q000601:surgery*; D001211:Asia, Western; D002387:Cataract Extraction / Q000009:adverse effects* / Q000379:methods; D002452:Cell Count; D002470:Cell Survival; D004728:Endothelium, Corneal / Q000473:pathology*; D005260:Female; D006801:Humans; D007429:Intraocular Pressure; D007431:Intraoperative Complications; D019654:Lens Implantation, Intraocular; D007910:Lenses, Intraocular; D008297:Male; D008875:Middle Aged; D014792:Visual Acuity