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Report for Clinical Trial NCT01860534

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

"Eye Protection After Mydriatic Use for ROP Screening: Impact on Vitals Signs and Pain Scores"

Pupillary dilation induced by mydriatic agents during Retinopathy of Prematurity exams can persist for hours. Despite regular use of eye protection for mydriatic-induced light sensitivity for infants, children and adults, eye protection after mydriasis has not been addressed in neonates. This study examines the use of eye patches to protect the dilated pupil from light exposure and their impact on vital signs and pain scores. prevents tachycardia, tachypnea and discomfort in neonates after ROP screening.

NCT01860534 Light Sensitivity
MeSH: Photophobia
HPO: Photophobia

1 Interventions

Name: eye covers

Description: The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.

Type: Behavioral

Eye patches covers


Primary Outcomes

Description: At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Heart rate was recorded directly from their cardio-respiratory monitor (Agilent M1106C). The mean of the five recorded values for each variable was used

Measure: Heart Rate

Time: pre-mydriasis, 1 hour and 3 hours after mydriatic drops

Secondary Outcomes

Description: At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Respiratory rate was recorded directly from their cardio-respiratory monitor (Agilent M1106C). The mean of the five recorded values for each variable was used

Measure: Respiratory Rate

Time: pre-mydriasis, 1 hour and 3 hours after mydriatic drops

Description: At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Oxygen percent saturation was recorded directly from their cardio-respiratory monitor (Agilent M1106C). The mean of the five recorded values for each variable was used

Measure: Oxygen Percent Saturation

Time: pre-mydriasis, 1 hour and 3 hours after mydriatic drops

Description: At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Pain scores were recorded by direct observation using the Neonatal and Infant Pain Scale (NIPS). The mean of the five recorded values for each variable was used. NIPS scoring consists of 6 measures associated with neonatal or infant pain, each with a range of 0-7 with low scores (0-2) associated with no pain and scores > to 4 associated with severe pain. Maximum scoring would be 42 for severe pain and minimal being 0 for no pain. The six measures on NIPS include: facial expression, crying, breathing patterns, arm movements, leg movements and state of arousal.

Measure: Pain

Time: pre-mydriasis, 1 hour and 3 hours after mydriatic drops

Purpose: Supportive Care

Allocation: Randomized

Crossover Assignment


There is one SNP

SNPs


1 M1106C

Heart rate was recorded directly from their cardio-respiratory monitor (Agilent M1106C). --- M1106C ---

Respiratory rate was recorded directly from their cardio-respiratory monitor (Agilent M1106C). --- M1106C ---

Oxygen percent saturation was recorded directly from their cardio-respiratory monitor (Agilent M1106C). --- M1106C ---



HPO Nodes


HPO:
Photophobia
Genes 303
TIMM8A PDE6A IDH3A OPN1MW ABCA4 ZNF408 GTF2H5 AP3D1 CCR1 ERCC2 CABP4 SLC1A3 RHO PCARE ALDH3A2 TP63 MBTPS2 RP1 ERCC2 CNGB3 IFT88 RPGRIP1 PDE6B RGR ATF6 TARS1 MITF XPC RAX2 TTC8 RPGR PROM1 ERCC2 NEK2 CA4 CA4 PRPH2 RHO PDE6H SCAPER CACNA1F HK1 HLA-B SNRNP200 GJB6 HLA-A GJB6 CRB1 EYS COL17A1 TYR PNPLA6 DRAM2 PRPF4 FOXE3 MBTPS2 ARL6 ATXN7 RDH12 GNAT2 PRPH2 ARL3 CACNA2D4 RLBP1 PITPNM3 TAT NR2E3 RNF113A SEMA4A ERCC4 ARL2BP AHR PRPF31 MAPT DKK1 GUCA1A PRCD RLBP1 CEP78 LYST PCNA POC1B CTNS OPN1LW UNC119 CHST6 LRAT SLC6A19 HPS6 ERCC6 PITPNM3 CDHR1 DHDDS CDHR1 ATF6 NMNAT1 IFT140 OPN1MW RP2 REEP6 LSS CNGA1 TYR PDE6C TYR CTNS ALDH3A2 ROM1 BBS2 WNT10A CFAP410 RTN4IP1 AP1B1 PRPF3 IL10 TNF ITM2B ALMS1 RPGRIP1 PRPH2 LRAT CRYGC POLH CACNA1F NMNAT1 IL12A-AS1 CRX CRX IL12A IL23R PRPF8 GUCA1B POMGNT1 SLC39A4 CERKL DDB2 CLRN1 KIAA1549 GUCA1A CNGA3 OPN1LW TACSTD2 TOPORS MBTPS2 GPR143 CNGA3 RAB28 TYR GUCA1A GNAT2 CST6 CFAP410 USH2A GJB6 LTBP2 GUCY2D C8ORF37 ST14 XPA RGS9 GJB2 FOXC2 AIRE PRPF6 NLRP3 MCOLN1 ZNF408 ADAM9 ITGB6 MPLKIP PRPH2 PROM1 ERCC2 RAX2 HGSNAT PRPH2 SEMA4A TGFBI CNGB3 BEST1 ERAP1 HADHA RPE65 GPR143 IDH3B LYST C8ORF37 TUB PIKFYVE OPN1MW DRAM2 TGFBI OPN1LW ABCA4 ANTXR1 KCNV2 RP9 SLC1A3 ZNF513 SLC24A5 TP63 AP3B1 CRX NOD2 KLHL7 RBP3 C8ORF37 KRT12 EYS SLC24A5 ALMS1 RDH5 LRMDA CNGA3 NR2E3 TYR ERCC3 RPE65 CHST6 POLA1 MAK FOXC2 PDE6C AHI1 FAS IMPDH1 MFRP OCA2 GNAT2 RPGR AGBL5 TTC8 TULP1 MCOLN1 ELOVL1 CNNM4 DHX38 TLR4 SCN1A KCNJ13 AIPL1 FAM161A TTLL5 MAPT NRL STAT4 ERCC5 IKZF1 AHSG PCYT1A CEP250 IMPG2 CNNM4 CACNA2D4 GNB3 SEMA4A RPGR HLA-DRB1 CNGB3 GUCY2D GTF2E2 PDE6H TIMM8A ESR1 KLRC4 RIMS1 XPA UBAC2 HLA-B KIZ C4A EDNRA SPATA7 DDB2 PRPH2 MERTK MC1R SLC45A2 NLRP1 CTNS OVOL2 GUCY2D MEFV PDE6C SLC7A14 RGS9BP PDE6G CDHR1 ARHGEF18 SAG HARS1 XPC ERCC3 ATF6 PLCD1 GJB2 OFD1 FSCN2 IFT172 RPGRIP1 POLH RPGR CNGB1