Collaborative Corneal Transplantation Studies (CCTS)

NCT00000137 | Completed Phase 3

• 1 other identifier: NEI-36
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine whether histocompatibility matching of corneal transplant donors and recipients can reduce the incidence of graft rejection in high-risk patients.

Conditions

Corneal Transplantation; Graft Rejection

Interventions

Histocompatibility Matching PROCEDURE

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Males and females age 10 years or older with two to four quadrants of corneal stroma vascularization or a history of allograft rejection in the eye considered for surgery were eligible for both studies in the CCTS. Patients must have been willing to participate in 3 years of followup. No one was eligible for the CCTS who had a condition that would greatly increase the risk of nonrejection graft failure, such as xerophthalmia or severe exposure keratopathy. Also excluded were patients with systemic diseases or with medication usage that might alter their immune response.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Related Publications (9)

• Stark WJ, Stulting RD, Thoft R. HLA matching and corneal transplantation. N Engl J Med. 1987 Dec 3;317(23):1476-7. doi: 10.1056/NEJM198712033172311. No abstract available.

  PMID: 3317044 BACKGROUND

• Klein PK; Stark WJ; Maguire MG; Stulting RD; Collaborative Corneal Transplantation Research Group; Donor-recipient crossmatching and typing to avoid corneal allograft rejection, in Cavanaugh HD (ed)., The Cornea: The World Congress on the Cornea III, New York, Raven Press, 1988:395-398

  BACKGROUND

• Stark WJ, Stulting RD, Meyer RF, Foulks GN, Smith RE, Chandler JW, Maguire MG, Bias WB. Sharing tissue typing information from the collaborative corneal transplantation studies. Arch Ophthalmol. 1989 May;107(5):633. doi: 10.1001/archopht.1989.01070010651004. No abstract available.

  PMID: 2655566 BACKGROUND

• The collaborative corneal transplantation studies (CCTS). Effectiveness of histocompatibility matching in high-risk corneal transplantation. The Collaborative Corneal Transplantation Studies Research Group. Arch Ophthalmol. 1992 Oct;110(10):1392-403.

  PMID: 1417537 BACKGROUND

• McDonnell PJ, Enger C, Stark WJ, Stulting RD. Corneal thickness changes after high-risk penetrating keratoplasty. Collaborative Corneal Transplantation Study Group. Arch Ophthalmol. 1993 Oct;111(10):1374-81. doi: 10.1001/archopht.1993.01090100082032.

  PMID: 8216018 BACKGROUND

• Fink N, Stark WJ, Maguire MG, Stulting D, Meyer R, Foulks G, Smith RE, Rapoza P. Effectiveness of histocompatibility matching in high-risk corneal transplantation: a summary of results from the Collaborative Corneal Transplantation Studies. Cesk Oftalmol. 1994 Feb;50(1):3-12.

  PMID: 8137435 BACKGROUND

• Maguire MG, Stark WJ, Gottsch JD, Stulting RD, Sugar A, Fink NE, Schwartz A. Risk factors for corneal graft failure and rejection in the collaborative corneal transplantation studies. Collaborative Corneal Transplantation Studies Research Group. Ophthalmology. 1994 Sep;101(9):1536-47. doi: 10.1016/s0161-6420(94)31138-9.

  PMID: 8090456 BACKGROUND

• Hahn AB, Foulks GN, Enger C, Fink N, Stark WJ, Hopkins KA, Sanfilippo F. The association of lymphocytotoxic antibodies with corneal allograft rejection in high risk patients. The Collaborative Corneal Transplantation Studies Research Group. Transplantation. 1995 Jan 15;59(1):21-7. doi: 10.1097/00007890-199501150-00005.

  PMID: 7839424 BACKGROUND

• Kamp MT, Fink NE, Enger C, Maguire MG, Stark WJ, Stulting RD. Patient-reported symptoms associated with graft reactions in high-risk patients in the collaborative corneal transplantation studies. Collaborative Corneal Transplantation Studies Research Group. Cornea. 1995 Jan;14(1):43-8.

  PMID: 7712736 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 23, 1999
• First Posted: September 24, 1999
• Study Start: May 1, 1986
• Study Completion: September 1, 1989
• Last Updated: September 17, 2009

Record last verified: 2009-09