Comparing deep sclerectomy with collagen implant to the new method of very deep sclerectomy with collagen implant: a single-masked randomized controlled trial.
OBJECTIVE
To prospectively study the intraocular pressure (IOP) lowering effect and safety of the new method of very deep sclerectomy with collagen implant (VDSCI) compared with standard deep sclerectomy with collagen implant (DSCI).


METHODS
The trial involved 50 eyes of 48 patients with medically uncontrolled primary and secondary open-angle glaucoma, randomized to undergo either VDSCI procedure (25 eyes) or DSCI procedure (25 eyes). Follow-up examinations were performed before surgery and after surgery at day 1, at week 1, at months 1, 2, 3, 6, 9, 12, 18, and 24 months. Ultrasound biomicroscopy was performed at 3 and 12 months.


RESULTS
Mean follow-up period was 18.6+/-5.9 (VDSCI) and 18.9+/-3.6 (DSCI) months (P=NS). Mean preoperative IOP was 22.4+/-7.4 mm Hg for VDSCI and 20.4+/-4.4 mm Hg for DSCI eyes (P=NS). Mean postoperative IOP was 3.9+/-2.3 (VDSCI) and 6.3+/-4.3 (DSCI) (P<0.05) at day 1, and 12.2+/-3.9 (VDSCI) and 13.3+/-3.4 (DSCI) (P=NS) at month 24. At the last visit, the complete success rate (defined as an IOP of < or =18 mm Hg and a percentage drop of at least 20%, achieved without medication) was 57% in VDSCI and 62% in DSCI eyes (P=NS) ultrasound biomicroscopy at 12 months showed a mean volume of the subconjunctival filtering bleb of 3.9+/-4.2 mm3 (VDSCI) and 6.8+/-7.5 mm3 (DSCI) (P=0.426) and 5.2+/-3.6 mm3 (VDSCI) and 5.4+/-2.9 mm3 (DSCI) (P=0.902) for the intrascleral space.


CONCLUSIONS
Very deep sclerectomy seems to provide stable and good control of IOP at 2 years of follow-up with few postoperative complications similar to standard deep sclerectomy with the collagen implant.
Mansouri
Kaweh
K
Jules Gonin Eye Hospital, Department of Ophthalmology, University of Lausanne, Lausanne, Switzerland. kawehm@yahoo.com
Tran
Hoai Viet
HV
Ravinet
Emilie
E
Mermoud
André
A
D000368:Aged; D003094:Collagen; D005260:Female; D005500:Follow-Up Studies; D005902:Glaucoma, Open-Angle / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D007429:Intraocular Pressure / Q000502:physiology; D008297:Male; D033401:Microscopy, Acoustic; D008875:Middle Aged; D011446:Prospective Studies; D019736:Prostheses and Implants; D012590:Sclera / Q000000981:diagnostic imaging / Q000601:surgery*; D012599:Sclerostomy / Q000379:methods*; D016037:Single-Blind Method; D016896:Treatment Outcome
D003094:Collagen