Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) - Outcome Study of Cryotherapy for Retinopathy of Prematurity

NCT00000133 | Completed

• 1 other identifier: NEI-32
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 24

Brief Summary

To determine the safety and efficacy of trans-scleral cryotherapy of the peripheral retina in certain low birth-weight infants with retinopathy of prematurity (ROP) for reducing blindness from ROP. To determine the long-term outcome for eyes that had severe ("threshold") ROP, both with and without cryotherapy.

Conditions

Retinopathy of Prematurity

Interventions

Trans-scleral Cryotherapy PROCEDURE

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Premature infants of either gender who were eligible for the natural history study had weighed less than 1,251 grams at birth and had survived the first 28 days of life. They had no major ocular or systemic congenital anomalies. Infants who met these criteria and also had a threshold level of ROP (defined as stage 3+ of the International Classification of Retinopathy of Prematurity occupying five or more contiguous or eight cumulative 30 degree sectors \[clock hours\] of stage 3 ROP in zone I or II in the presence of plus disease) could be referred for examination to determine eligibility for entry to the cryotherapy trial.

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

Study Sites (24)

Alabama Ophthalmology Associates, P.C.

Birmingham, Alabama, United States

Location

Private practice of David Plotsky, MD

Washington D.C., District of Columbia, United States

Location

Retina Group of Washington

Washington D.C., District of Columbia, United States

Location

Bascom Palmer Eye Institute, University of Miami School of Medicine

Miami, Florida, United States

Location

University of Illinois Eye and Ear Infirmary

Chicago, Illinois, United States

Location

Department of Ophthalmology, Indiana University School of Medicine

Indianapolis, Indiana, United States

Location

Kentucky Lions Eye Research Institute, University of Louisville

Louisville, Kentucky, United States

Location

Department of Ophthalmology, Tulane University School of Medicine

New Orleans, Louisiana, United States

Location

Wilmer Eye Institute, The Johns Hopkins Medical Institutions

Baltimore, Maryland, United States

Location

Private practice of John D. Baker, MD

Dearborn, Michigan, United States

Location

Associated Retinal Consultants, P.C.

Royal Oak, Michigan, United States

Location

Department of Ophthalmology, University of Minnesota

Minneapolis, Minnesota, United States

Location

Strong Children's Hospital, University of Rochester Medical Center

Rochester, New York, United States

Location

Duke University Medical Center

Durham, North Carolina, United States

Location

Private Practice of Miles J. Burke, MD

Cincinnati, Ohio, United States

Location

Columbus Children's Hospital

Columbus, Ohio, United States

Location

Oregon Health & Science University, Casey Eye Institute

Portland, Oregon, United States

Location

Children's Hospital of Philadelphia, Division of Pediatric Ophthalmology

Philadelphia, Pennsylvania, United States

Location

Pediatric Ophthalmology and Strabismus, Inc.

Pittsburgh, Pennsylvania, United States

Location

Storm Eye Institute, Medical University of South Carolina

Charleston, South Carolina, United States

Location

Department of Ophthalmology, Vanderbilt University Medical Center

Nashville, Tennessee, United States

Location

Private practice of Rand Spencer, M.D.

Dallas, Texas, United States

Location

University of Texas Health Science Center, San Antonio, Department of Ophthalmology

San Antonio, Texas, United States

Location

John Moran Eye Center

Salt Lake City, Utah, United States

Location

Related Publications (32)

• Multicenter trial of cryotherapy for retinopathy of prematurity: preliminary results. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Pediatrics. 1988 May;81(5):697-706.

  PMID: 2895910 BACKGROUND

• Multicenter trial of cryotherapy for retinopathy of prematurity. Three-month outcome. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1990 Feb;108(2):195-204. doi: 10.1001/archopht.1990.01070040047029.

  PMID: 2405827 BACKGROUND

• Dobson V, Quinn GE, Biglan AW, Tung B, Flynn JT, Palmer EA. Acuity card assessment of visual function in the cryotherapy for retinopathy of prematurity trial. Invest Ophthalmol Vis Sci. 1990 Sep;31(9):1702-8.

  PMID: 2211019 BACKGROUND

• Watzke RC, Robertson JE Jr, Palmer EA, Wallace PR, Evans MS, Soldevilla JE. Photographic grading in the retinopathy of prematurity cryotherapy trial. Arch Ophthalmol. 1990 Jul;108(7):950-5. doi: 10.1001/archopht.1990.01070090052038.

  PMID: 2369354 BACKGROUND

• Hardy RJ, Davis BR, Palmer EA, Tung B. Statistical considerations in terminating randomization in the Multicenter Trial of Cryotherapy for Retinopathy of Prematurity. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Control Clin Trials. 1991 Apr;12(2):293-303. doi: 10.1016/0197-2456(91)90026-i.

  PMID: 1645641 BACKGROUND

• Palmer EA, Flynn JT, Hardy RJ, Phelps DL, Phillips CL, Schaffer DB, Tung B. Incidence and early course of retinopathy of prematurity. The Cryotherapy for Retinopathy of Prematurity Cooperative Group. Ophthalmology. 1991 Nov;98(11):1628-40. doi: 10.1016/s0161-6420(91)32074-8.

  PMID: 1800923 BACKGROUND

• Palmer EA, Hardy RJ, Davis BR, Stein JA, Mowery RL, Tung B, Phelps DL, Schaffer DB, Flynn JT, Phillips CL. Operational aspects of terminating randomization in the Multicenter Trial of Cryotherapy for Retinopathy of Prematurity. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Control Clin Trials. 1991 Apr;12(2):277-92. doi: 10.1016/0197-2456(91)90025-h.

  PMID: 1645640 BACKGROUND

• Phelps DL, Brown DR, Tung B, Cassady G, McClead RE, Purohit DM, Palmer EA. 28-day survival rates of 6676 neonates with birth weights of 1250 grams or less. Pediatrics. 1991 Jan;87(1):7-17.

  PMID: 1984621 BACKGROUND

• Quinn GE, Dobson V, Barr CC, Davis BR, Flynn JT, Palmer EA, Robertson J, Trese MT. Visual acuity in infants after vitrectomy for severe retinopathy of prematurity. Ophthalmology. 1991 Jan;98(1):5-13. doi: 10.1016/s0161-6420(91)32343-1.

  PMID: 2023732 BACKGROUND

• Gilbert WS, Dobson V, Quinn GE, Reynolds J, Tung B, Flynn JT. The correlation of visual function with posterior retinal structure in severe retinopathy of prematurity. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1992 May;110(5):625-31. doi: 10.1001/archopht.1992.01080170047022.

  PMID: 1580837 BACKGROUND

• Quinn GE, Dobson V, Repka MX, Reynolds J, Kivlin J, Davis B, Buckley E, Flynn JT, Palmer EA. Development of myopia in infants with birth weights less than 1251 grams. The Cryotherapy for Retinopathy of Prematurity Cooperative Group. Ophthalmology. 1992 Mar;99(3):329-40. doi: 10.1016/s0161-6420(92)31968-2.

  PMID: 1565444 BACKGROUND

• Summers G, Phelps DL, Tung B, Palmer EA. Ocular cosmesis in retinopathy of prematurity. The Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1992 Aug;110(8):1092-7. doi: 10.1001/archopht.1992.01080200072027.

  PMID: 1497522 BACKGROUND

• Trueb L; Evans J; Hammel A; Bartholomew P; Dobson D; Assessing visual acuity of visually impaired children using the Teller acuity cards., Am Orthoptic J 1992;42:149-154

  BACKGROUND

• Multicenter trial of cryotherapy for retinopathy of prematurity. 3 1/2-year outcome--structure and function. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1993 Mar;111(3):339-44.

  PMID: 8447743 BACKGROUND

• Evans MS; Wallace PR; Palmer EA; Fundus photography in small infants., J Ophthal Photography 1993;15(1):38-39

  BACKGROUND

• Reynolds J, Dobson V, Quinn GE, Gilbert WS, Tung B, Robertson J, Flynn JT. Prediction of visual function in eyes with mild to moderate posterior pole residua of retinopathy of prematurity. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1993 Aug;111(8):1050-6. doi: 10.1001/archopht.1993.01090080046017.

  PMID: 8352687 BACKGROUND

• Schaffer DB, Palmer EA, Plotsky DF, Metz HS, Flynn JT, Tung B, Hardy RJ. Prognostic factors in the natural course of retinopathy of prematurity. The Cryotherapy for Retinopathy of Prematurity Cooperative Group. Ophthalmology. 1993 Feb;100(2):230-7. doi: 10.1016/s0161-6420(93)31665-9.

  PMID: 8437832 BACKGROUND

• The natural ocular outcome of premature birth and retinopathy. Status at 1 year. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1994 Jul;112(7):903-12. doi: 10.1001/archopht.1994.01090190051021.

  PMID: 8031269 BACKGROUND

• Dobson V, Quinn GE, Summers CG, Saunders RA, Phelps DL, Tung B, Palmer EA. Effect of acute-phase retinopathy of prematurity on grating acuity development in the very low birth weight infant. The Cryotherapy for Retinopathy of Prematurity Cooperative Group. Invest Ophthalmol Vis Sci. 1994 Dec;35(13):4236-44.

  PMID: 8002243 BACKGROUND

• Dobson V, Quinn GE, Saunders RA, Spencer R, Davis BR, Risser J, Palmer EA. Grating visual acuity in eyes with retinal residua of retinopathy of prematurity. The Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1995 Sep;113(9):1172-7. doi: 10.1001/archopht.1995.01100090098029.

  PMID: 7661752 BACKGROUND

• Dobson V, Quinn GE, Tung B, Palmer EA, Reynolds JD. Comparison of recognition and grating acuities in very-low-birth-weight children with and without retinal residua of retinopathy of prematurity. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Invest Ophthalmol Vis Sci. 1995 Mar;36(3):692-702.

  PMID: 7890499 BACKGROUND

• Kivlin JD, Biglan AW, Gordon RA, Dobson V, Hardy RA, Palmer EA, Tung B, Gilbert W, Spencer R, Cheng KP, Buckley E. Early retinal vessel development and iris vessel dilatation as factors in retinopathy of prematurity. Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) Cooperative Group. Arch Ophthalmol. 1996 Feb;114(2):150-4. doi: 10.1001/archopht.1996.01100130144005.

  PMID: 8573016 BACKGROUND

• Quinn GE, Dobson V, Biglan A, Evans J, Plotsky D, Hardy RJ. Correlation of retinopathy of prematurity in fellow eyes in the cryotherapy for retinopathy of prematurity study. The Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1995 Apr;113(4):469-73. doi: 10.1001/archopht.1995.01100040089032.

  PMID: 7710397 BACKGROUND

• Bartholomew PA; Chao J; Evans JL; Hammel AM; Trueb AL; Verness JL; Dobson V; Quinn GE; Acceptance/Use of the Teller acuity card procedure in the clinic., Am Orthoptic J 1996;46:100-106

  BACKGROUND

• Cryotherapy for Retinopathy of Prematurity Cooperative Group. Multicenter trial of cryotherapy for retinopathy of prematurity. Snellen visual acuity and structural outcome at 5 1/2 years after randomization. Arch Ophthalmol. 1996 Apr;114(4):417-24. doi: 10.1001/archopht.1996.01100130413008.

  PMID: 8602778 BACKGROUND

• Dobson V, Quinn GE, Abramov I, Hardy RJ, Tung B, Siatkowski RM, Phelps DL. Color vision measured with pseudoisochromatic plates at five-and-a-half years in eyes of children from the CRYO-ROP study. Invest Ophthalmol Vis Sci. 1996 Nov;37(12):2467-74.

  PMID: 8933763 BACKGROUND

• Gilbert WS, Quinn GE, Dobson V, Reynolds J, Hardy RJ, Palmer EA. Partial retinal detachment at 3 months after threshold retinopathy of prematurity. Long-term structural and functional outcome. Multicenter Trial of Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1996 Sep;114(9):1085-91. doi: 10.1001/archopht.1996.01100140287005.

  PMID: 8790093 BACKGROUND

• Quinn GE, Dobson V, Barr CC, Davis BR, Palmer EA, Robertson J, Summers CG, Trese MT, Tung B. Visual acuity of eyes after vitrectomy for retinopathy of prematurity: follow-up at 5 1/2 years. The Cryotherapy for Retinopathy of Prematurity Cooperative Group. Ophthalmology. 1996 Apr;103(4):595-600. doi: 10.1016/s0161-6420(96)30647-7.

  PMID: 8618758 BACKGROUND

• Quinn GE, Dobson V, Hardy RJ, Tung B, Phelps DL, Palmer EA. Visual fields measured with double-arc perimetry in eyes with threshold retinopathy of prematurity from the cryotherapy for retinopathy of prematurity trial. The CRYO-Retinopathy of Prematurity Cooperative Group. Ophthalmology. 1996 Sep;103(9):1432-7. doi: 10.1016/s0161-6420(96)30487-9.

  PMID: 8841302 BACKGROUND

• Hardy RJ, Palmer EA, Schaffer DB, Phelps DL, Davis BR, Cooper CJ. Outcome-based management of retinopathy of prematurity. Multicenter Trial of Cryotherapy for Retinopathy of prematurity Cooperative Group. J AAPOS. 1997 Mar;1(1):46-54. doi: 10.1016/s1091-8531(97)90023-9.

  PMID: 10530985 BACKGROUND

• Saunders RA, Donahue ML, Christmann LM, Pakalnis AV, Tung B, Hardy RJ, Phelps DL. Racial variation in retinopathy of prematurity. The Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1997 May;115(5):604-8. doi: 10.1001/archopht.1997.01100150606005.

  PMID: 9152127 BACKGROUND

• Multicenter trial of cryotherapy for retinopathy of prematurity. Preliminary results. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1988 Apr;106(4):471-9. doi: 10.1001/archopht.1988.01060130517027.

  PMID: 2895630 BACKGROUND

MeSH Terms

Conditions

Retinopathy of Prematurity

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 23, 1999
• First Posted: September 24, 1999
• Study Start: January 1, 1986
• Study Completion: August 1, 2003
• Last Updated: February 4, 2014

Record last verified: 2003-10

Locations

US (24)