Evaluating the long-term efficacy of short-duration 0.1 mg/ml and 0.2 mg/ml MMC in primary trabeculectomy for primary adult glaucoma.
OBJECTIVE
To evaluate safety and efficacy of 0.1 mg/ml versus 0.2 mg/ml mitomycin-C (MMC), applied for 1 min subconjunctivally, during trabeculectomy for primary adult glaucoma in previously un-operated eyes.


METHODS
This is a randomised controlled, non-inferior, clinical trial consisting of 50 consecutive POAG or CPACG patients uncontrolled on maximal hypotensive therapy, meeting all inclusion criteria. Patients were randomized into two groups and underwent a standard limbus-based trabeculectomy with MMC: Group I, 0.1 mg/ml and Group II, 0.2 mg/ml. The pre-operative and post-operative intraocular pressure (IOP), bleb morphology, and visual acuity were recorded every 6 months for 2 years. Complete success (primary outcome) was defined as IOP ≤ 15 mmHg without any additional medications at the end of 2 years.


RESULTS
The average age of patients was 62.6 ± 9.8 years and 61.2 ± 8.1 years in Group 1 and 2, respectively; p = 0.57. The mean preoperative IOP was 22.5 ± 1.4 mmHg and 23.3 ± 1.8 mmHg; p = 0.10. The mean IOP at 2 years was 11.1 ± 1.6 mmHg and 10.8 ± 2.8 mmHg, a mean reduction in IOP of 50.6 ± 1.23 %, and 53.7 ± 2.25 % in Group I and II, respectively. The complete success was 92.0 % and 91.7 % in the two groups, respectively (p = 0.99), and there was one failure (Group II, post trauma). A wider bleb extent and larger areas of thin, transparent conjunctiva over the bleb were seen with the 0.2 mg/ml MMC group (p < 0.001) and in PACG eyes; p < 0.04.


CONCLUSIONS
A 1-min subconjunctival application of low dose 0.1 mg/ml MMC is non-inferior to 0.2 mg/ml and is probably a safer alternative, as thinning of the bleb is significantly less frequent in the long term.
Glaucoma Research Facility & Clinical Services, Dr Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, Room no.-495, fourth floor, New Delhi, 110029, India, rjsihota@gmail.com.
Ramanjit
R
Sihota
Dewang
D
Angmo
Anuradha
A
Chandra
Viney
V
Gupta
Ajay
A
Sharma
R M
RM
Pandey
D000368:Aged; D000477:Alkylating Agents / Q000008:administration & dosage*; D003131:Combined Modality Therapy; D003228:Conjunctiva / Q000187:drug effects*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D015812:Glaucoma, Angle-Closure / Q000188:drug therapy / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D005902:Glaucoma, Open-Angle / Q000188:drug therapy / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D006801:Humans; D007429:Intraocular Pressure / Q000502:physiology; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage*; D011446:Prospective Studies; D013810:Therapeutic Equivalency; D013997:Time Factors; D014065:Tonometry, Ocular; D014130:Trabeculectomy; D016896:Treatment Outcome; D058609:Visual Field Tests
D000477:Alkylating Agents; D016685:Mitomycin