The Madurai Intraocular Lens Study. II: Clinical outcomes.
OBJECTIVE
To evaluate the safety and efficacy of extracapsular cataract extraction with posterior chamber intraocular lens (ECCE/PC-IOL) compared with intracapsular cataract extraction with aphakic glasses (ICCE-AG).


METHODS
In a nonmasked randomized controlled clinical trial, 3,400 bilaterally vision-impaired patients aged 40 to 75 years with operable cataract were randomly assigned to receive either ICCE-AG or ECCE/PC-IOL at the Aravind Eye Hospital in India. The surgery was performed by one of four study surgeons. Patients were hospitalized for 5 postoperative days, with follow-up visits at 2, 6, and 12 months after discharge. Postsurgery evaluations were conducted by two independent study ophthalmologists.


RESULTS
At any single postoperative follow-up time point, there were no statistically significant differences of clinical relevance between treatment groups for any complication of a serious nature except cystoid macular edema, which was more common with ICCE (4.2% vs 1.6%). In general, whether of a trivial, intermediate, or serious nature, complication rates were low at each evaluation time point. Cumulatively, the incidence of serious complications of all types throughout the 1-year study period was 14.5% for patients in the ICCE-AG group and 7.7% in the ECCE group (P < .001). Best-corrected visual acuity of 20/40 or better at 12 months was attained by 90.7% of ICCE-AG patients and 96.3% of ECCE/PC-IOL patients (P < .001).


CONCLUSIONS
Although both operative procedures are safe and effective for cataract patients with bilateral impairment, ECCE/PC-IOL is superior to ICCE-AG in terms of both visual acuity restoration and safety.
Prajna
N V
NV
Aravind Eye Hospital and Post-Graduate Institute of Ophthalmology, Madurai, India.
Chandrakanth
K S
KS
Kim
R
R
Narendran
V
V
Selvakumar
S
S
Rohini
G
G
Manoharan
N
N
Bangdiwala
S I
SI
Ellwein
L B
LB
Kupfer
C
C
D000328:Adult; D000368:Aged; D002387:Cataract Extraction / Q000379:methods*; D005139:Eyeglasses; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D007194:India; D007431:Intraoperative Complications; D019654:Lens Implantation, Intraocular; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D012449:Safety; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology*