title: Adjuvant Role of Amniotic Membrane Transplantation in Acute Ocular Stevens-Johnson Syndrome: A Randomized Control Trial.
abstract: OBJECTIVE
  To evaluate the adjuvant role of amniotic membrane transplantation (AMT) in cases of acute ocular Stevens-Johnson syndrome (SJS).
  
  
  METHODS
  Prospective randomized controlled clinical trial.
  
  
  METHODS
  Twenty-five patients (50 eyes) with acute ocular SJS who presented within 4 weeks of onset of symptoms were recruited.
  
  
  METHODS
  The eyes were randomized into 2 groups that underwent either AMT with medical therapy (MT; n = 25) or standard MT alone (n = 25). The patients were evaluated at presentation and during follow-up at 1 week and 1, 3, and 6 months. The parameters evaluated were the best-corrected visual acuity (BCVA), Schirmer test, tear film breakup time (TBUT), conjunctival congestion, corneal haze, vascularization, conjunctivalization, and limbal stem cell involvement. Lid edema, symblepharon, ankyloblepharon, ectropion, entropion, trichiasis, and metaplastic lashes also were analyzed.
  
  
  METHODS
  Maintenance of BCVA and stable ocular surface.
  
  
  RESULTS
  At the end of 6 months, the mean BCVA was significantly better in the AMT group (0.068±0.10 logMAR units) compared with the MT group (0.522±0.52 logMAR units; P = 0.042). The mean TBUT in the AMT and MT groups was 9.92±4.1 and 6.96±4.5 seconds, respectively (P = 0.015). The mean Schirmer test results in the AMT and MT groups were 15.4±6.3 and 8.64±5.4 mm, respectively (P < 0.001). Conjunctival congestion persisted in 44% (11/25) in the MT group compared with 4% (1/25) in the AMT group (P = 0.03) at the end of the 6-month follow-up. No case in the AMT group demonstrated corneal haze, limbal stem cell deficiency, symblepharon, ankyloblepharon, or lid-related complications. Among eyes in the MT group, corneal haze occurred in 44% (11/25; P = 0.001), corneal vascularization and conjunctivalization in 24% (6/25; P = 0.03), symblepharon in 16% (4/25; P = 0.12), ankyloblepharon in 4% (1/25; P = 1.00), ectropion and entropion in 8% (2/25; P = 0.47), and trichiasis and metaplastic lashes in 24% (6/25; P = 0.03) eyes.
  
  
  CONCLUSIONS
  Amniotic membrane transplantation is a useful adjunct to conventional MT in maintaining BCVA and a stable ocular surface in cases of acute ocular SJS. Furthermore, the adjunctive use of AMT also helps to prevent intermediate-term ocular cicatricial sequelae.
authors.affiliation: Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India. Electronic address: namrata.sharma@gmail.com.
authors.forename: Namrata
authors.initials: N
authors.lastname: Sharma
authors.affiliation: Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: S A
authors.initials: SA
authors.lastname: Thenarasun
authors.affiliation: Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Manpreet
authors.initials: M
authors.lastname: Kaur
authors.affiliation: Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Neelam
authors.initials: N
authors.lastname: Pushker
authors.affiliation: Department of Dermatology, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Neena
authors.initials: N
authors.lastname: Khanna
authors.affiliation: Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Tushar
authors.initials: T
authors.lastname: Agarwal
authors.affiliation: Vision Eye Institute, Royal Victorian Eye and Ear Hospital, North West Academic Centre, University of Melbourne, Melbourne, Australia.
authors.forename: Rasik B
authors.initials: RB
authors.lastname: Vajpayee
mesh_terms: D000208:Acute Disease; D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000650:Amnion / Q000637:transplantation*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D002701:Chloramphenicol / Q000627:therapeutic use; D003231:Conjunctivitis / Q000188:drug therapy / Q000503:physiopathology / Q000601:surgery*; D003316:Corneal Diseases / Q000188:drug therapy / Q000503:physiopathology / Q000601:surgery*; D004338:Drug Combinations; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions; D011112:Polymyxin B / Q000627:therapeutic use; D011239:Prednisolone / Q000627:therapeutic use; D011446:Prospective Studies; D013262:Stevens-Johnson Syndrome / Q000188:drug therapy / Q000503:physiopathology / Q000601:surgery*; D014792:Visual Acuity / Q000502:physiology; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D004338:Drug Combinations; D005938:Glucocorticoids; D009883:Ophthalmic Solutions; D002701:Chloramphenicol; D011239:Prednisolone; D011112:Polymyxin B