Safety and efficacy of phacoemulsification compared with manual small-incision cataract surgery by a randomized controlled clinical trial: six-week results.
OBJECTIVE
To compare the efficacy, safety, and refractive errors of astigmatism after cataract surgery by phacoemulsification and manual small-incision cataract surgery techniques.


METHODS
Masked randomized control clinical trial.


METHODS
Four hundred eyes of 400 patients, 1:1 randomization with half in each arm of the trial.


METHODS
A total of 400 eyes was assigned randomly to either phacoemulsification or small-incision groups after informed consent and were operated on by 4 surgeons. They were masked to the technique of surgery before, during, and after cataract surgery and followed up to 1 year after surgery. The intraoperative and postoperative complications, uncorrected and best-corrected visual acuity, and astigmatism were recorded at 1 and 6 weeks postoperatively.


METHODS
The proportion of patients achieving visual acuity better than or equal to 6/18 with and without spectacles after cataract surgery in the operated eye up to 6 weeks, postoperative astigmatism, and complications during and after surgery.


RESULTS
This article reports clinical outcomes up to 6 weeks. Three hundred eighty-three of 400 (95.75%) patients completed the 1-week follow-up, and 372 of 400 (93%) patients completed the 6-week follow-up. One hundred thirty-one of 192 (68.2%) patients in the phacoemulsification group and 117 of 191 (61.25%) patients in the small-incision group had uncorrected visual acuity better than or equal to 6/18 at 1 week (P = 0.153). One hundred fifty of 185 (81.08%) patients of the phacoemulsification group and 133 of 187 (71.1%) patients of the small-incision group (P = 0.038) were better than or equal to 6/18 at the 6-week follow-up for presenting visual activity. Visual acuity improved to > or = 6/18 with best correction in 182 of 185 patients (98.4%) and 184 of 187 (98.4%) patients (P = 0.549), respectively. Poor outcome (postoperative visual acuity < 6/60) was noted in 1 of 185 (0.5%) in the phacoemulsification group and none in the small-incision group. The mode of astigmatism was 0.5 diopters (D) for the phacoemulsification group and 1.5 D for the small-incision group, and the average astigmatism was 1.1 D and 1.2 D, respectively. There was an intra-surgeon variation in astigmatism. The phacoemulsification group had 7 posterior capsular rents compared with 12 in the small-incision group, but the phacoemulsification group had more corneal edema on the first postoperative day.


CONCLUSIONS
Both the phacoemulsification and the small-incision techniques are safe and effective for visual rehabilitation of cataract patients, although phacoemulsification gives better uncorrected visual acuity in a larger proportion of patients at 6 weeks.
Gogate
Parikshit M
PM
H. V. Desai Eye Hospital, Pune, India.
Kulkarni
Sucheta R
SR
Krishnaiah
S
S
Deshpande
Rahul D
RD
Joshi
Shilpa A
SA
Palimkar
Anand
A
Deshpande
Madan D
MD
D001251:Astigmatism / Q000503:physiopathology; D002387:Cataract Extraction / Q000379:methods*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007431:Intraoperative Complications; D008297:Male; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures / Q000379:methods; D018918:Phacoemulsification / Q000379:methods*; D011183:Postoperative Complications; D012030:Refractive Errors / Q000503:physiopathology; D012449:Safety; D016896:Treatment Outcome; D014792:Visual Acuity